Intraoperative Lidocaine and Combined With Ketamine on Opioid After Bariatric Surgery
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| ClinicalTrials.gov Identifier: NCT04524130 |
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Recruitment Status :
Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : February 24, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Laparoscopic Bariatric Surgery | Drug: Lidocaine Hydrochloride Drug: Ketamine Drug: Placebo | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 87 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Intraoperative Lidocaine Infusion and Intraoperative Lidocaine Combined With Ketamine Infusion on Opioid Consumption After Laparoscopic Bariatric Surgery: A Randomized Controlled Trial |
| Estimated Study Start Date : | April 1, 2021 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | June 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: Lidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
Other Name: Li Drug: Ketamine Ketamine will be given 0.35 mg/kg bolus at induction then 0.2 mg/kg/hr until the end of surgery.
Other Name: Ke |
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Active Comparator: 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.
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Drug: Lidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
Other Name: Li Drug: Placebo Normal saline will be given with the same rate of lidocaine or ketamine.
Other Name: Normal Saline |
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Placebo Comparator: Placebo
Participants in this arm will receive normal saline, same volume as lidocaine and ketamine.
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Drug: Placebo
Normal saline will be given with the same rate of lidocaine or ketamine.
Other Name: Normal Saline |
- Opioid consumption [ Time Frame: 24-hour ]Opioid consumption at 24 hr post-operation using Morphine Milligram equivalents(MME)
- Score of post-extubation cough [ Time Frame: 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.
- operative time [ Time Frame: intraoperative (since the incision started until finished the last suture) ]time since incision started until the last suture done recorded in minutes.
- anesthetic time [ Time Frame: 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.
- the length of hospital stay [ Time Frame: until 30-day postoperation ]time since admission until discharge recorded in hours.
- numbers of participants with postoperative complications [ Time Frame: until 30-day postoperation ]cardiac arrhythmia, myocardial infarction, respiratory compromised, reintubation, readmission.
- Score of sore throat [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults patients age older than 18 years.
- Body mass index more than 30 kg/m2.
- 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:
- Patient refusal.
- Inability to communicate or read in Thai language.
- Allergic to lidocaine or ketamine.
- History of opioid use within 2 weeks before surgery
- Cardiovascular disorder, including high grade atrioventricular block (second degree or third degree), history of coronary artery disease, poor controlled hypertension.
- History of stroke, intracranial hemorrhage or intracranial mass
- Cognitive impairment
- Schizophrenia or history of antipsychotic drugs
- Pregnant or breast-feeding patients
- Conversion to open surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524130
| Contact: Parichat Tovikkai, MD. | 66-8605302344 | Parichat.nil@mahidol.ac.th |
| Principal Investigator: | Parichat Tovikkai | Mahidol University |
| Responsible Party: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT04524130 |
| Other Study ID Numbers: |
610/2563(IRB3) |
| First Posted: | August 24, 2020 Key Record Dates |
| Last Update Posted: | February 24, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Lidocaine Ketamine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers |
Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Analgesics Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents |