|Year : 2015 | Volume
| Issue : 1 | Page : 64-69
Topical lidocaine against deep sedation for intragastric balloon insertion
Ayman A Kasem, Ashraf A AbdelKader
Department of Anesthesia, Ain Shams University, Cairo, Egypt
|Date of Submission||27-May-2014|
|Date of Acceptance||20-Oct-2014|
|Date of Web Publication||25-Mar-2015|
Ayman A Kasem
Ain Shams University Hospitals, Cairo
Source of Support: None, Conflict of Interest: None
Intragastric balloon (IGB) insertion is a known method for the treatment of the special group of morbidly obese patients. The procedure can be performed under general anesthesia or deep sedation; however, it is associated with many complications, particularly respiratory complications, in this risky group of patients, which makes topical anesthesia an acceptable alternative option.
The aim of this study was to demonstrate the efficacy of topical anesthesia for IGB insertion in comparison with the deep-sedation technique.
Patients and methods
A total of 100 patients were enrolled in the study, and were divided into two groups. The T group received topical anesthesia in the form of lidocaine gel ± lidocaine spray. If the patient did not tolerate the endoscope advancement, either midazolam or alfentanil was given, whereas S group patients received deep sedation in the form of alfentanil, propofol, and midazolam.
Endoscopy was performed in all patients successfully. The topical group had more hemodynamic stability, less respiratory adverse events, a shorter time to return to baseline condition, and higher patient satisfaction compared with the other group.
The use of topical anesthesia is an effective technique for IGB insertion as it provides a good operative condition and a safer procedure for high-risk morbidly obese patients, with high patient satisfaction.
Keywords: intragastric balloon insertion, lidocaine, sedation
|How to cite this article:|
Kasem AA, AbdelKader AA. Topical lidocaine against deep sedation for intragastric balloon insertion. Ain-Shams J Anaesthesiol 2015;8:64-9
|How to cite this URL:|
Kasem AA, AbdelKader AA. Topical lidocaine against deep sedation for intragastric balloon insertion. Ain-Shams J Anaesthesiol [serial online] 2015 [cited 2021 May 6];8:64-9. Available from: http://www.asja.eg.net/text.asp?2015/8/1/64/153940
| Introduction|| |
The prevalence of obesity has increased markedly over the last two decades and has generated considerable concern about its health burdens. It is stated frequently in scientific literature that obesity causes about 300 000 deaths per year in the USA. It has been suggested that obesity is second only to smoking as a preventable cause of death  . Obesity is classified according to the BMI as follows: people who exceed 30 kg/m 2 are considered as obese, whereas those who exceed 35 kg/m 2 are morbidly obese  .
Obesity has become a common health problem affecting the whole population in Saudi Arabia. On the basis of the National Nutrition Survey of 2007, the prevalence of obesity in Kingdom of Saudi Arabia was 23.6% in women and 14% in men. The prevalence of overweight in the community was determined to be 30.7% among men as compared with 28.4% among women. Similarly, the prevalence of obesity among the adult population estimated by the Coronary Artery Disease in Saudis Study (CADISS) in 2005 was 35.6%; in other words, one in every three people in the country is obese , .
Managing obesity should consist of a combination of behavior modification, a calorie-restricted diet, and physical activity. Pharmacotherapy is recommended for patients who fail to achieve a weight reduction of 5-10% in 3-6 months, whereas a surgical approach is indicated for extremely obese patients (BMI > 40 kg/m 2 ). The intragastric balloon (IGB) is indicated for those who neither respond to medical therapy nor are surgical candidates  .
IGB was first described in 1982 for the treatment of obesity and morbid obesity. However, due to poor balloon designs, its use was associated with numerous complications (spontaneous and early deflations, balloon displacement, and intestinal obstruction)  .
Improvement in the design in the 1990s led to the introduction of a new clinically accepted balloon to the market, the bioenterics intragastric balloon (BIB), which is used as a temporary treatment before surgery  .
Insertion and removal of the IGB have been tried using different anesthetic techniques: topical anesthesia, conscious sedation, deep sedation, and general anesthesia. Conscious sedation is frequently associated with patient discomfort, whereas deep sedation and general anesthesia may lead to life-threatening obesity-related complications ,, .
The aim of this study was to demonstrate the efficacy of topical anesthesia for IGB insertion in comparison with the deep-sedation technique.
| Patients and methods|| |
This study was conducted in the Day-Surgery Unit of King Abdul-Aziz Airbase Hospital, Dhahran, Kingdom of Saudi Arabia. The study protocol was approved by the Ethics Committee of the hospital, and after obtaining a written informed consent, 100 morbidly obese adult patients scheduled for IGB insertion were enrolled (BMI ≥ 35 kg/m²).
Exclusion criteria included ASA physical status III or IV, age less than 18 and more than 50 years, significant comorbidities, allergy to lidocaine, pregnancy, and alcohol and drug abuse. The balloon was not inserted in patients with esophagitis, hiatus hernia, gastritis, gastric mass, or peptic ulcer as diagnosed by endoscopy.
Patients were allocated randomly to the topical group (T) and the sedation group (S) by a closed envelop technique.
In the S group, patients received 5 µg/kg alfentanil, midazolam 3 mg intravenously with a bolus dose of 50 mg propofol, followed by a propofol 1 mg/kg/h infusion. Additional increments of 100 μg alfentanil ± propofol bolus 50 mg ± midazolam 1 mg were given to achieve a Ramsay sedation score  ([Table 1]) between 3 and 4; the procedure was then started by allowing the endoscopist to advance the gastroscope. If the patient was not resisting and not reacting to the endoscopic advancement, the procedure was continued, but if there was a reaction, either additional alfentanil 100 μg intravenously midazolam 1 mg intravenously or propofol 20 mg increments alone or in combination was given till acceptable endoscopic advancement was achieved.
In the T group, 10 ml of lidocaine gel (20 mg/ml) (Rialocaine; Riyadh Pharma, Riyadh) was placed in a 10 ml syringe body; the syringe piston was attached to the syringe body again and the lidocaine was pushed into the patient's mouth; the patient was asked to move it inside his/her mouth for 3 min and then swallow the remaining lidocaine.
After 3 min, the gag reflex was tested by touching the posterior part of the tongue with a tongue depressor: if significant gag was still present, additional lidocaine spray 10% [Avocaine Spray (10% 50 ml); Avalon Pharma] was used in each peritonsillar bed, one puff (10 mg). The procedure of the gag test and spray was repeated every 90 s till acceptable gag was achieved with a maximum of 10 puffs (100 mg) in each patient; 500 mg lidocaine in total should not be exceeded. After achieving satisfactory gag, the surgeon was allowed to start the procedure, and the patient's response was assessed; if there was no reaction, the procedure was continued, but if there was a reaction, either increments of alfentanil 100 μg or midazolam 1 mg intravenously or both was given depending on the patient's type of reaction (pain or anxiety). If the incremental amount of the required alfentanil exceeded 5µg/kg or midazolam more than 3 mg, the patient was considered as having failed the topical anesthesia technique and was recorded.
Oxygen supplementation through a nasal cannula at 2 l/min was introduced to all patients in both groups. All patients received 8 mg ondansetron intravenously and 4 mg dexamethasone intravenously before the start of the procedure. Standard monitoring of patients included recording the heart rate (HR), the blood pressure (BP), the respiratory rate, oxygen saturation, and end-tidal CO 2 (Dinamap Pro 1000, GE Healthcare Bio-Sciences, Pittsburgh, PA 15264-3065, USA) (before the start of the procedure and every 5 min during the procedure).
After advancing the gastroscope, the endoscopist rated the gag reflex in both groups on a scale from 1 to 4 (where, 1 = no discomfort, 2 = slight discomfort, 3 = moderate discomfort, and 4 = severe discomfort)  .
Intraprocedural events such as unwanted movement, retching, nausea, vomiting, laryngospasm, shivering, agitation, and others were recorded.
At the end of the procedure and before removing the gastroscope, the endoscopist was asked to perform good suctioning to decrease the remaining intragastric secretions to decrease the incidence of postoperative nausea and vomiting and risk of aspiration. After the procedure, the endoscopist determined the ease of the procedure (with respect to the technique used) on a scale from 1 to 4 (where 1 = very easy, 2 = easy, 3 = difficult, and 4 = very difficult)  .
The time from sedation administration in the S group and topical administration in the T group till satisfactory advancement of the endoscope (procedure onset time) was recorded. The number of trials of endoscope advancement in each patient was also recorded in both groups.
Total amounts of any medications used (including the use of reversal drugs during the procedure) were recorded.
Any events such as apnea, hypopnea, or desaturation were recorded; other events such as procedure hold, cancelling, or airway assistance were also recorded.
After the procedure, patients were transferred and monitored in the recovery room. Symptoms such as sore throat, difficulty swallowing, nausea, vomiting, abdominal pain, dyspnea, cough, or inability to cough were recorded. Any medications in the recovery area including antiemetics and reversal drugs (flumazenil and naloxone) were recorded. Afterward, a questionnaire was filled up by asking the patients about their satisfaction to the procedure on a scale of 5 (1 = very satisfied, 5 = very upset).
Patients may be discharged home once they fulfilled the home readiness discharge criteria including full consciousness, hemodynamic stability, return of adequate gag reflex, and the ability to swallow clear fluids safely. If a reversal agent was used, patients were not discharged except after 2 h regardless of the time they fulfill the discharge criteria.
Patients were discharged only with a competent companion and were instructed not to drive, operate heavy or potentially harmful machinery, or make legally binding decisions. Written instructions on discharge are necessary as the amnesic period after sedation is variable.
Postprocedure instructions on the signs and symptoms of potential adverse outcomes and complications are also advisable. Patients should be given written instructions on the steps to follow in the event of a complication, including a phone number where 24-h-a-day help is available in the event of an emergency.
The primary outcome was the proportion of participants with a successful first-attempt endoscopy. Secondary outcomes included hemodynamic stability, respiratory adverse events, time to return to baseline condition, and patient satisfaction.
Using PASS for sample size calculation, it was calculated that a sample size of 45 per group will achieve 80% power to detect a difference of 50% in patient satisfaction between the two groups with a significance level (α) of 0.05 using a two-sided two-sample t-test: 50 patients per group were included to replace any drop out.
All statistical calculations were carried out using the computer program statistical package for the social science(SPSS Inc., Chicago, Illinois, USA) version 17 for Microsoft Windows. Data were expressed as mean values ± SD and numbers (%). Student's t-test was used to analyze parametric data; discrete (categorical) variables were analyzed using the χ2 -test, and nonparametric data were compared using the Mann-Whitney test, with P values less than 0.05 were considered statistically significant.
| Results|| |
A total of 100 patients were enrolled in this study: 50 patients in each group. As shown in [Table 2], no differences were found between the two study groups regarding their age, sex, ASA classification, and BMI.
Endoscopy was performed in all patients successfully. However, IGB was not inserted in six patients in group T and in seven patients in group S. [Table 3] shows the reason for IGB insertion cancellation in both groups.
The HR and the mean arterial BP were significantly lower in group S compared with group T (P<0.005). Two patients in group S developed a HR less than 50 and were treated with intravenous atropine, whereas no patients developed such an incident in group T. Also, respiratory rate and oxygen saturation (%) were significantly lower in group S compared with group T ([Table 4]).
Respiratory adverse events were significantly higher in group S compared with group T ([Table 5]).
No difference was found between the two groups regarding their gag reflex, unwanted movement, retching, nausea, vomiting, laryngospasm, shivering, agitation, and others (P values were not significant).
As shown in [Table 6], the onset time was significantly shorter in group S compared with group T and the number of patients satisfied with the procedure was significantly higher in group T compared with group S, whereas the endoscopist's rating of the ease of the procedure was the same in both groups.
First-attempt endoscopy was successful in the majority of the patients; however, seven patients in group S and five patients in group T required supplementary medications to tolerate the second endoscopic attempt successfully. No patient required a third endoscopic attempt in both groups.
Induction and intraoperative doses of alfentanyl and midazolam, and the total propofol dose given to patients, were significantly higher in group S compared with group T ([Table 7]).
|Table 6 Procedure onset time, ease of the procedure, and patient satisfaction|
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Regarding postoperative symptoms including nausea, vomiting, abdominal pain, and sore throat, there was no significant difference between the two study groups.
The time to home readiness in minutes was shorter in group T compared with group S (65 ± 10 and 81 ± 13, respectively). All patients achieved discharge criteria and tolerated fluid oral intake with no coughing or choking, and no patients required the use of reversal agents or hospital admission.
| Discussion|| |
The BIB is a well-known adjuvant therapy in weight reduction for the management of morbidly obese patients , . Usually, the balloon is used to decrease anesthesia and surgical risks of bariatric surgical procedures in patients with life-threatening complications or very high BMI.
Different anesthetic managements for BIB placement and positioning have been described. Better airway control after endotracheal intubation is the only real advantage of general anesthesia for IGB positioning compared with conscious or deep sedation. Difficult intubation in obese patients with a higher inhalation risk during laryngoscopy is a serious concern if general anesthesia is planned. Other disadvantages of general anesthesia include positioning problem (intraoperatively and postoperatively), a longer hospital stay, and the higher cost of the resources used  .
Inhibition of the gag reflex is the main action of local oropharyngeal anesthesia, which is considered to be one of the most important factors affecting patient tolerance to the procedure  .
The results of this study show that topical anesthesia was found to be effective, and the endoscopy was successful in all patients and was equally accepted by the endoscopist compared with deep sedation, with better patient satisfaction.
Topical anesthesia was reported to be effective for upper gastrointestinal endoscopy. Mogensen et al.  , who used lidocaine lozenges as a topical anesthesia for upper gastrointestinal endoscopy, concluded that the lozenge reduced the gag reflex, diminished patients' discomfort, and improved patients' acceptance during upper gastrointestinal endoscopy.
Ayoub et al.  used lidocaine lollipop as a single-agent anesthesia in upper gastrointestinal endoscopy and found it to be a promising, well-tolerated, and safe form of local oropharyngeal anesthesia for upper gastrointestinal endoscopy.
Messina and colleagues studied 3824 patients for BIB insertion and removal over 8 years, and compared three different methods: topical anesthesia, sedation, and general anesthesia. They found topical anesthesia and sedation to be effective methods with reduced incidence of major events compared with general anesthesia, and they recommended not using general anesthesia for BIB insertion and removal  .
In this study, HR and BP were significantly higher in group T compared with group S. This is not surprising as most of the patients in group T were treated under topical anesthesia without any sedation. In contrast to this result, Messina et al.  found no significant hemodynamic instability between patients receiving topical anesthesia and those who received deep sedation. This discrepancy can be explained by the use of either diazepam (0.05-0.1 mg/kg intravenously) or midazolam (0.03-0.05 mg/kg intravenously) in their topical group of patients.
Morbidly obese patients are at a higher risk for respiratory complications when sedation or general anesthesia is planned. Topical anesthesia seems to be an acceptable choice to provide respiratory stability and good oxygen saturation in this risky group of patients. In our study, no patient reported an oxygen saturation less than 90% and there was no need for assisted ventilation in any patient in group T, whereas in group S, the incidence of oxygen saturation less than 90% occurred in six patients (12%), five patients (10%) developed apnea, and seven patients (14%) required assisted mask ventilation. The significantly greater use of dormicum, alfentanil, and propofol explains the higher number of respiratory adverse events in group S patients.
In agreement with our study, Messina et al.  found that the incidence of oxygen desaturation less than 90% was 4.6 and 11.6% and the incidence of assisted mask ventilation was 0 and 0.6% in the T and the S groups, respectively. Also, Coskun and Aksakal  , in their experience with deep sedation with propofol in 102 cases of IGB positioning and 63 cases of removal, observed two cases (1.2%) of prominently marked hypoventilation.
The time to return from sedation to baseline, mental functions, and the time to home discharge were significantly longer in group S patients compared with group T. These results match the results of Messina et al.  . This may be of greater significance for busy or higher centers.
The maximum recorded lidocaine dose used in this study was 285 mg. We believe that this dose is safe (although we did not measure the serum lidocaine level) as the dose used was within the recommended dose of 5 mg/kg and did not exceed the potentially toxic dose of 500 mg  . Moreover, higher doses of topical lidocaine have been used in prior studies. Sutherland et al.  , for instance, utilized topical doses of 380 mg of lidocaine and concluded that the blood levels were still within the therapeutic range.
| Conclusion|| |
Topical anesthesia seems to be an effective technique for BIB insertion as it provides a good operative condition, a safer procedure for high-risk morbidly obese patients, and high patient satisfaction.
| Acknowledgements|| |
Conflicts of interest
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]