Analgesia Management in Bariatric Surgery
Primary Purpose
Morbid Obesity, Bariatric Surgery Candidate, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lidocain
Ketamine
Dexmedetomidine
Sponsored by
About this trial
This is an interventional supportive care trial for Morbid Obesity focused on measuring Dexmedetomidine, Ketamine, Lidocaine, Obesity, Morbid, Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- Ondokuz Mayis University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group L
Group K
Group D
Arm Description
IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours.
IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
Outcomes
Primary Outcome Measures
Postoperative pain: VAS scores at rest and movement
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).
Secondary Outcome Measures
Postoperative Rescue Analgesic Requirement
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
The number of patients who has complained of nausea, retching and vomiting will be recorded.
Time to first mobilization
The patients first mobilization time after the operation will be recorded.
Time to discharge
The length of hospital stay will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04836819
Brief Title
Analgesia Management in Bariatric Surgery
Official Title
Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
June 5, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Bariatric Surgery Candidate, Pain, Postoperative
Keywords
Dexmedetomidine, Ketamine, Lidocaine, Obesity, Morbid, Pain, Postoperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomly classified into three groups.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group L
Arm Type
Active Comparator
Arm Description
IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours.
Arm Title
Group K
Arm Type
Active Comparator
Arm Description
IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
Intervention Type
Drug
Intervention Name(s)
Lidocain
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain: VAS scores at rest and movement
Description
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).
Time Frame
Up to 15 days after the surgery.
Secondary Outcome Measure Information:
Title
Postoperative Rescue Analgesic Requirement
Description
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.
Time Frame
Up to three days after surgery
Title
Postoperative nausea, retching and vomiting
Description
The number of patients who has complained of nausea, retching and vomiting will be recorded.
Time Frame
Up to 3 days after surgery.
Title
Time to first mobilization
Description
The patients first mobilization time after the operation will be recorded.
Time Frame
Up to 24 hours after surgery.
Title
Time to discharge
Description
The length of hospital stay will be recorded.
Time Frame
Trough hospital stay, an average of 1 week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ersin Koksal
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ondokuz Mayis University
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55270
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31256367
Citation
Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3.
Results Reference
background
PubMed Identifier
16517328
Citation
Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009.
Results Reference
background
PubMed Identifier
21773855
Citation
Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.
Results Reference
background
PubMed Identifier
30474791
Citation
Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1.
Results Reference
background
PubMed Identifier
28120147
Citation
Bamgbade OA, Oluwole O, Khaw RR. Perioperative Analgesia for Fast-Track Laparoscopic Bariatric Surgery. Obes Surg. 2017 Jul;27(7):1828-1834. doi: 10.1007/s11695-017-2562-4.
Results Reference
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Analgesia Management in Bariatric Surgery
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