Intraoperative Lidocaine and Combined With Ketamine on Opioid After Bariatric Surgery
NCT ID: NCT04524130
Last Updated: 2025-05-09
Study Results
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Basic Information
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COMPLETED
PHASE4
87 participants
INTERVENTIONAL
2021-04-01
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lidocaine and Ketamine
Participants in this arm will receive intra-operative lidocaine and ketamine infusion as adjunctive drugs for pain control. All medication is dosed based on calculated lean body weight (LBW) by Janmahasatian formula.
Lidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
Ketamine
Ketamine will be given 0.35 mg/kg bolus at induction then 0.2 mg/kg/hr until the end of surgery.
Lidocaine
Participants in this arm will receive only intra-operative ketamine infusion as adjunctive drugs for pain control. All medication is dosed based on calculated lean body weight (LBW) by Janmahasatian formula.
Lidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
Placebo
Normal saline will be given with the same rate of lidocaine or ketamine.
Placebo
Participants in this arm will receive normal saline, same volume as lidocaine and ketamine.
Placebo
Normal saline will be given with the same rate of lidocaine or ketamine.
Interventions
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Lidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
Ketamine
Ketamine will be given 0.35 mg/kg bolus at induction then 0.2 mg/kg/hr until the end of surgery.
Placebo
Normal saline will be given with the same rate of lidocaine or ketamine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Parichat Tovikkai
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of medicine Siriraj hospital
Bangkok, Bangkok, Thailand
Countries
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References
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Other Identifiers
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610/2563(IRB3)
Identifier Type: -
Identifier Source: org_study_id
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