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Opioid Free Anesthesia in Bariatric Surgery

Primary Purpose

Opioid Use, Postoperative Pain, Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Opioid free Anesthesia dexmedetomidine and lidocaine
Opioid based anesthesia Fentanyl and Remifentanyl
Sponsored by
Lebanese American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring Lidocaine, Dexmedetomidine, Opioid Free, Bariatric surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age group: 18-65 years old
  • American Society of Anesthesiologists (ASA )class I and II
  • Indicated laparoscopic bariatric surgery

Exclusion Criteria:

  • Renal, hepatic or cardiac insufficiency
  • Positive pregnancy test
  • Alcohol or drug abuse
  • Psychiatric disease
  • History of chronic pain
  • Allergy or contraindication to any of the study drugs

Sites / Locations

  • LAU Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Opioid Based Anesthesia

Opioid Free Anesthesia

Arm Description

General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl and Sevoflurane.

General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine and Sevoflurane.

Outcomes

Primary Outcome Measures

Postoperative pain score for 48 hours
Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 and every 6 hours up to 48 hours post surgery.

Secondary Outcome Measures

Postoperative morphine consumption at the PACU (Post Anesthesia Care Unit)
After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented.
Postoperative morphine consumption at the surgical ward for 48 hours
Post-operative opioid consumption will be based on the amount in mg (milligrams) of opioid required in the 48 hours postoperative.
Postoperative morphine Side effects: Sedation score .for 48 hours
Sedation score: 0 alert Mild, drowsy , easy to awake moderate, easy to arouse Severe: somnolent difficult to arouse 4:sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and then every 6 hours up to 48 hours.
Postoperative morphine Side effects:Respiratory depression for 48 hours
Assess the respiratory rate : The number of breaths per minute. In practice, the respiratory rate is usually determined by counting the number of times the chest rises or falls per minute. The respiratory rate will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and then every 6 hours up to 48 hours.
Postoperative morphine Side effects: Nausea vomiting for 48 hours
Degree of nausea vomiting using the verbal rating score from 0 to 10 : 0= no nausea/ Vomiting, 10: worst possible nausea vomiting. The degree of nausea vomiting will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Postoperative morphine Side effects: Itching for 48 hours
Itching: presence or absence The presence or absence of itching will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.

Full Information

First Posted
April 12, 2018
Last Updated
September 28, 2020
Sponsor
Lebanese American University
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1. Study Identification

Unique Protocol Identification Number
NCT03507634
Brief Title
Opioid Free Anesthesia in Bariatric Surgery
Official Title
Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lebanese American 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
This study compares the intraoperative opioid free anesthesia approach in laparoscopic bariatric surgery to a conventional opioid- based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine
Detailed Description
Since optimal analgesia for the obese patients undergoing bariatric surgeries has always been challenging, and knowing the comorbidities and physiological changes in this population, use of opioid-sparing agents during anesthesia has attracted substantial research.the use of opioids in the perioperative period in obese patients is associated with an increased risk of complications . They are especially more sensitive to the respiratory depressant effect of opioids , thus any analgesic alternative without further compromising airway tone would be a desirable choice. Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic and sedative properties, without compromising airway tone and reflexes . Lidocaine, a local anesthetic that has been shown to be an effective multimodal strategy to minimize postoperative pain was evaluated in one study involving obese patients undergoing bariatric surgery. Its usage was associated with an improved quality of recovery compared to placebo .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Postoperative Pain, Postoperative Nausea and Vomiting, Bariatric Surgery Candidate
Keywords
Lidocaine, Dexmedetomidine, Opioid Free, Bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opioid Based Anesthesia
Arm Type
Active Comparator
Arm Description
General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl and Sevoflurane.
Arm Title
Opioid Free Anesthesia
Arm Type
Active Comparator
Arm Description
General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine and Sevoflurane.
Intervention Type
Drug
Intervention Name(s)
Opioid free Anesthesia dexmedetomidine and lidocaine
Intervention Description
Opioid free anesthesia with dexmedetomidine and lidocaine
Intervention Type
Drug
Intervention Name(s)
Opioid based anesthesia Fentanyl and Remifentanyl
Intervention Description
Opioid based anesthesia with Fentanyl and Remifentanyl
Primary Outcome Measure Information:
Title
Postoperative pain score for 48 hours
Description
Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 and every 6 hours up to 48 hours post surgery.
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative morphine consumption at the PACU (Post Anesthesia Care Unit)
Description
After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented.
Time Frame
2 hours postoperative
Title
Postoperative morphine consumption at the surgical ward for 48 hours
Description
Post-operative opioid consumption will be based on the amount in mg (milligrams) of opioid required in the 48 hours postoperative.
Time Frame
48 hours postoperative
Title
Postoperative morphine Side effects: Sedation score .for 48 hours
Description
Sedation score: 0 alert Mild, drowsy , easy to awake moderate, easy to arouse Severe: somnolent difficult to arouse 4:sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and then every 6 hours up to 48 hours.
Time Frame
48 hours postoperative
Title
Postoperative morphine Side effects:Respiratory depression for 48 hours
Description
Assess the respiratory rate : The number of breaths per minute. In practice, the respiratory rate is usually determined by counting the number of times the chest rises or falls per minute. The respiratory rate will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and then every 6 hours up to 48 hours.
Time Frame
48 hours postoperative
Title
Postoperative morphine Side effects: Nausea vomiting for 48 hours
Description
Degree of nausea vomiting using the verbal rating score from 0 to 10 : 0= no nausea/ Vomiting, 10: worst possible nausea vomiting. The degree of nausea vomiting will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Time Frame
48 hours postoperative
Title
Postoperative morphine Side effects: Itching for 48 hours
Description
Itching: presence or absence The presence or absence of itching will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Time Frame
48 hours postoperative

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: Age group: 18-65 years old American Society of Anesthesiologists (ASA )class I and II Indicated laparoscopic bariatric surgery Exclusion Criteria: Renal, hepatic or cardiac insufficiency Positive pregnancy test Alcohol or drug abuse Psychiatric disease History of chronic pain Allergy or contraindication to any of the study drugs
Facility Information:
Facility Name
LAU Medical Center
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No

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Opioid Free Anesthesia in Bariatric Surgery

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