Opioid Free Anesthesia in Bariatric Surgery

NCT03507634 | Completed

• 1 other identifier: LAUMCRH.HB2.28/Mar/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Opioid Use; Postoperative Pain; Postoperative Nausea and Vomiting; Bariatric Surgery Candidate

Keywords

Lidocaine; Dexmedetomidine; Opioid Free; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours postoperative

Secondary Outcomes (6)

• Postoperative morphine consumption at the PACU (Post Anesthesia Care Unit)

  2 hours postoperative

• Postoperative morphine consumption at the surgical ward for 48 hours

  48 hours postoperative

• Postoperative morphine Side effects: Sedation score .for 48 hours

  48 hours postoperative

• Postoperative morphine Side effects:Respiratory depression for 48 hours

  48 hours postoperative

• Postoperative morphine Side effects: Nausea vomiting for 48 hours

  48 hours postoperative

Study Arms (2)

Opioid Based Anesthesia

ACTIVE COMPARATOR

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.

Drug: Opioid based anesthesia Fentanyl and Remifentanyl

Opioid Free Anesthesia

ACTIVE COMPARATOR

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.

Drug: Opioid free Anesthesia dexmedetomidine and lidocaine

Interventions

Opioid free Anesthesia dexmedetomidine and lidocaine DRUG

Opioid free anesthesia with dexmedetomidine and lidocaine

Opioid Free Anesthesia

Opioid based anesthesia Fentanyl and Remifentanyl DRUG

Opioid based anesthesia with Fentanyl and Remifentanyl

Opioid Based Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lebanese American University: lead

Study Sites (1)

LAU Medical Center

Beirut, Lebanon

Location

Related Publications (1)

• Barakat H, Gholmieh L, Nader JA, Karam VY, Albaini O, Helou ME, Al Nawwar R. Opioid-free versus opioid-based anesthesia in laparoscopic sleeve gastrectomy: a single-center, randomized, controlled trial. Perioper Med (Lond). 2025 Feb 5;14(1):16. doi: 10.1186/s13741-024-00486-5.

  PMID: 39910664 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Lidocaine; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 25, 2018
• Study Start: April 11, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)