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Intraoperative Lidocaine and Combined With Ketamine on Opioid After Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524130
Recruitment Status : Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Tracking Information
First Submitted Date  ICMJE July 29, 2020
First Posted Date  ICMJE August 24, 2020
Last Update Posted Date August 24, 2020
Estimated Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Lidocaine and Combined With Ketamine on Opioid After Bariatric Surgery
Official Title  ICMJE The Effect of Intraoperative Lidocaine Infusion and Intraoperative Lidocaine Combined With Ketamine Infusion on Opioid Consumption After Laparoscopic Bariatric Surgery: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Laparoscopic Bariatric Surgery
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Normal saline will be given with the same rate of lidocaine or ketamine.
    Other Name: Normal Saline
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Lidocaine Hydrochloride
    • Drug: Ketamine
  • 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.
    Interventions:
    • Drug: Lidocaine Hydrochloride
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Participants in this arm will receive normal saline, same volume as lidocaine and ketamine.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2020)
87
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Parichat Tovikkai, MD. 66-8605302344 Parichat.nil@mahidol.ac.th
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04524130
Other Study ID Numbers  ICMJE 610/2563(IRB3)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Parichat Tovikkai Mahidol University
PRS Account Mahidol University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP