Laparoscopic Bariatric Surgery
Conditions
Brief summary
The most effective long-term treatment for obesity is bariatric surgery, however, postoperative pain control is challenging in these group of population. Opioid-sparing technique with multimodal analgesia is recommended but the evidence supported is still limited. Multimodal analgesia, particularly lidocaine and ketamine, has been used effectively in various type of surgery. However, the evidence supported their use in obese patients undergoing bariatric surgery is limited.
Detailed description
The prevalence of obesity and associated diseases have been increasing in recent decades. From 1980 to 2013, the number of adults with BMI more than 25 kg/m2 increased from 28.8% to 36.9% in men, and from 29.8% to 38% in women. According to World Health Organization (WHO), the prevalence of overweight among adults in Thailand in 2016 was 32.6%, markedly increased from 2011 which was 23.9%. To date, the most effective long-term treatment for obesity is bariatric surgery because of significantly reducing body fat, the development of new obesity-related conditions, and overall mortality. However, postoperative complications, particularly respiratory complication, are concerned because obesity is associated with respiratory compromise and sleep-disordered breathing. The 2016 guideline for perioperative care in bariatric surgery developed by enhanced recovery after surgery (ERAS) society state that, regarding to current evidence, there is no specific anesthetic agents or techniques for bariatric surgery, however, multimodal analgesia should be used to reduce opioid consumption and opioid-related complications such as respiratory depression, postoperative nausea and vomiting and ileus. Moreover, several studies supported opioid-sparing technique to avoid respiratory complications. Intravenous lidocaine is widely used to reduce postoperative pain and to reduce perioperative opioid as a multimodal analgesia. From Cochrane review, perioperative lidocaine can decrease pain at rest, postoperative ileus and postoperative nausea and vomiting in elective and urgent surgery. Few trials in obese patients underwent laparoscopic bariatric surgery found that lidocaine infusion can decrease opioid consumption. However, the supported evidence is still limit. Ketamine has been used for postoperative analgesia as well, as an effective adjunct to decrease opioid consumption in various types of surgery, including open bariatric surgery. Moreover, the recent retrospective study (Tovikkai P, in press) found that there was a positive interaction between intraoperative lidocaine infusion and ketamine for decreasing opioid consumption in obese patients underwent laparoscopic bariatric surgery. However, the benefit of lidocaine and ketamine for postoperative pain in obese patients underwent laparoscopic bariatric surgery is still debated. Therefore, we designed this study to examine the effect of intraoperative lidocaine infusion and intraoperative lidocaine infusion combined with intraoperative low-dose ketamine infusion on opioid consumption in obese patients undergoing laparoscopic bariatric surgery.
Interventions
DRUGPlacebo
Normal saline will be given with the same rate of lidocaine or ketamine.
DRUGLidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
DRUGKetamine
Ketamine will be given 0.35 mg/kg bolus at induction then 0.2 mg/kg/hr until the end of surgery.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults patients age older than 18 years. 2. Body mass index more than 30 kg/m2. 3. Scheduled for laparoscopic bariatric surgery, including laparoscopic sleeve gastrectomy, robotic-assisted laparoscopic sleeve gastrectomy, laparoscopic Roux-en-Y gastric bypass surgery or robotic-assisted laparoscopic gastric bypass.
Exclusion criteria
1. Patient refusal. 2. Inability to communicate or read in Thai language. 3. Allergic to lidocaine or ketamine. 4. History of opioid use within 2 weeks before surgery 5. Cardiovascular disorder, including high grade atrioventricular block (second degree or third degree), history of coronary artery disease, poor controlled hypertension. 6. History of stroke, intracranial hemorrhage or intracranial mass 7. Cognitive impairment 8. Schizophrenia or history of antipsychotic drugs 9. Pregnant or breast-feeding patients 10. Conversion to open surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 24-hour | Opioid consumption at 24 hr post-operation using Morphine Milligram equivalents(MME) |
| Score of post-extubation cough | up to 24 hours (at extubation period after surgery finished) | post-extubation cough graded by care giver using modified Minogue scales, which defined grade1 as no coughing or muscular stiffness, grade 2 as coughing once or twice, or transient cough response to removal of tracheal tube that resolved with extubation, grade 3 as ≤ 3 coughs lasting 1-2 seconds, or total duration of coughing last ≤ 5 seconds and grade 4 as ≥ 4 coughs with each lasting \> 2 seconds, total duration of coughing last \> 5 seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the length of hospital stay | until 30-day postoperation | time since admission until discharge recorded in hours. |
| operative time | intraoperative (since the incision started until finished the last suture) | time since incision started until the last suture done recorded in minutes. |
| Score of sore throat | assess at 24-hour post-operation | sore throat score grading by self-assessment score, which defined grade 0 as no sore throat, grade 1 as minimal sore throat, grade 2 as moderate sore throat and grade 3 as severe sore throat. |
| numbers of participants with postoperative complications | until 30-day postoperation | cardiac arrhythmia, myocardial infarction, respiratory compromised, reintubation, readmission. |
| anesthetic time | intraoperative (since anesthetic started until patient out of the operating room) | time since anesthetic started until finished and patient out of room recorded in minutes. |
Countries
Thailand
Outcome results
None listed