Opioid Sparing Anaesthesia for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery

Ketamine

Brief Summary

In spite of multimodal analgesic strategies, which consist of opioids, dexamethasone, non-steroidal anti-inflammatory drugs, and local anesthetics applied into the surgical wound, postoperative pain and postoperative nausea and vomiting (PONV) are still common complaints reported after laparoscopic gynecological surgery. So, it is hypothesized that the infusion consisting of lidocaine, dexmedetomidine and ketamine, as an opioid substitute was a feasible technique for laparoscopic gynecological surgery and would be associated with less incidence of PONV and lower opioid requirements in the early postoperative period. The aim of this study was to evaluate the effect of opioid sparing technique via infusion of Dexmedetomidine, Ketamine and Lidocaine on post-operative nausea and vomiting in laparoscopic gynecological surgery.

Intervention / Treatment

  • Dexmedetomidine, ketamine and lidocaine (DRUG)
    A loading infusion of syringe (B) containing the a mixture \[dexmedetomidine (2 µg/ml), ketamine (0.5 mg /ml) and lidocaine (4 mg /ml)\] was started at rate of 0.2 ml/kg/h ten minutes before induction. Then anesthesia was induced with 2 mg/kg IBW of propofol, patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (D) containing normal saline (as masking for fentanyl in the control group).
  • Normal saline (DRUG)
    A loading infusion of the 50 ml syringe (A) containing normal saline was started at rate of 0.2 ml/ kg/hr ten minutes before induction (as masking for mixture in group S). Then anesthesia was induced with 2 mg/kg ideal body weight (IBW) of propofol , patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (C) containing fentanyl (1mic/kg of IBW).

Condition or Disease

  • PONV
  • Opioid Sparing Anaesthesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 21 Years to 60 Years
    Enrollment: 80 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 15, 2021 ACTUAL
    Primary Completion: May 25, 2021 ACTUAL
    Completion Date: May 26, 2021 ACTUAL
    Study First Posted: Jan 13, 2021 ACTUAL
    Last Updated: May 26, 2021

    Sponsors / Collaborators

    Lead Sponsor: Tanta University
    Responsible Party: N/A

    Participant Groups

    • A loading infusion of the 50 ml syringe (A) containing normal saline was started at rate of 0.2 ml/ kg/hr ten minutes before induction (as masking for mixture in group S). Then anesthesia was induced with 2 mg/kg ideal body weight (IBW) of propofol , patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (C) containing fentanyl (1 mic/kg of IBW).

    • A loading infusion of syringe (B) containing the mixture was started at rate of 0.2 ml/kg/h ten minutes before induction. Then anesthesia was induced with 2 mg/kg IBW of propofol, patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (D) containing normal saline (as masking for fentanyl in the control group).

    Eligibility Criteria

    Sex: Female
    Minimum Age: 21
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patients scheduled for elective laparoscopic gynaecological surgery, who:

    * had the American Society of Anesthesiologists (ASA) I or II physical status,
    * were 21-60 years of age

    Exclusion Criteria:

    * A body mass index \>35 kg/ m2
    * Pregnant, breast feeding women
    * Hepatic, renal or cardiac insufficiency
    * Diabetes mellitus
    * History of chronic pain
    * Alcohol or drug abuse
    * Psychiatric disease
    * Allergy or contraindication to any of the study drugs

    Primary Outcomes

    • The total simplified PONV impact scale score ≥ 5

    Secondary Outcomes
    • Intraoperative isoflurane consumption Intraoperative 3 hours
    • Intraoperative fentanyl consumption Intraoperative 3 hours

    • First 24 hr morphine consumption according to visual analogue sale (VAS). If VAS is more than 3, Intravenous morphine titration was administered as a bolus of 2 mg (body weight ≤60 kg) or 3 mg (body weight \>60 kg) with 5-minute lockout interval between each bolus repeated till pain is relieved.

    More Details

    NCT Number: NCT04706897
    Other IDs: 33362/9/19
    Study URL: https://clinicaltrials.gov/study/NCT04706897
    Last updated: Sep 29, 2023