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Analgesia Management in Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT04836819
Recruitment Status : Completed
First Posted : April 8, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Yasemin Burcu Ustun, Ondokuz Mayıs University

Tracking Information
First Submitted Date  ICMJE April 5, 2021
First Posted Date  ICMJE April 8, 2021
Last Update Posted Date July 2, 2021
Actual Study Start Date  ICMJE April 8, 2021
Actual Primary Completion Date June 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
Postoperative pain: VAS scores at rest and movement [ Time Frame: Up to 15 days after the surgery. ]
Pain status at rest and movement will be assessed by VAS scores. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain imaginable).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
  • Postoperative Rescue Analgesic Requirement [ Time Frame: Up to three days after surgery ]
    After the end of surgery 25-50 mg meperidine (maximum dose 200 mg) will be administered i.m. as rescue analgesia when requested by the patient and if VAS>4. the Rescue analgesic dosage will be recorded.
  • Postoperative nausea, retching and vomiting [ Time Frame: Up to 3 days after surgery. ]
    The number of patients who has complained of nausea, retching and vomiting will be recorded.
  • Time to first mobilization [ Time Frame: Up to 24 hours after surgery. ]
    The patients first mobilization time after the operation will be recorded.
  • Time to discharge [ Time Frame: Trough hospital stay, an average of 1 week. ]
    The length of hospital stay will be recorded.
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 Analgesia Management in Bariatric Surgery
Official Title  ICMJE Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial
Brief Summary Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as components of multimodal analgesia in bariatric surgery. The present study is aimed to compare lidocaine, dexmedetomidine, and ketamine in multimodal analgesia management following Sleeve Gastrectomy Surgery. Postoperative pain scores, the requirement for additional postoperative analgesia, retching, nausea and vomiting, time to mobilization, and hospital length of stay will be evaluated.
Detailed Description

Patients will be divided into three groups.

Group L: The patients will receive intravenous lidocaine (2 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 1 mg/kg/h. The infusion will continue until 12 hours after the operation.

Group K: The patients will receive intravenous ketamine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.

Group D: The patients will receive intravenous dexmedetomidine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.

Ketamine, lidocaine, and dexmedetomidine doses will be calculated according to ideal body weight, lean body weight, and actual body weight, respectively.

Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group will be placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group mentioned in the envelope.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The patients will be randomly classified into three groups.
Masking: Double (Participant, Investigator)
Masking Description:
Drugs to be used will be prepared 30 minutes before the surgery in the drug preparation room by a nurse who is not involved in the study. Investigators and patients will be blinded to the group assignments.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Morbid Obesity
  • Bariatric Surgery Candidate
  • Pain
  • Postoperative
Intervention  ICMJE
  • Drug: Lidocain
    IV lidocaine infusion (2 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 1 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
  • Drug: Ketamine
    IV ketamine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
  • Drug: Dexmedetomidine
    IV dexmedetomidine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
Study Arms  ICMJE
  • Active Comparator: Group L
    IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours.
    Intervention: Drug: Lidocain
  • Active Comparator: Group K
    IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
    Intervention: Drug: Ketamine
  • Active Comparator: Group D
    IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
    Intervention: Drug: Dexmedetomidine
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2021)
78
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2021
Actual Primary Completion Date June 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index>35 kg/m2
  • The American Society of Anaesthesiologists (ASA) physical status class II III
  • Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)

Exclusion Criteria:

  • refusal to participate
  • allergy to the study drugs
  • chronic kidney disease (creatinine>150 μmol/L)
  • mental illness
  • liver, respiratory or oncological disease,
  • cardiac dysfunction (ejection fraction <40%),
  • uncontrolled hypertension,
  • preoperative analgesic use,
  • chronic pain,
  • history of alcohol or drug addiction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04836819
Other Study ID Numbers  ICMJE SGPAM-DKL11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yasemin Burcu Ustun, Ondokuz Mayıs University
Study Sponsor  ICMJE Ondokuz Mayıs University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ersin Koksal Ondokuz Mayıs University
PRS Account Ondokuz Mayıs University
Verification Date July 2021

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