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NCT Number: NCT04706897

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

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.

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Key information

Conditions

PONV Nausea Opioid Sparing Anaesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

21 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Tanta University

Tanta, ElGharbiaa, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. The incidence of postoperative nausea and vomiting (PONV)

    Time frame: First 24 hours postoperative

    The total simplified PONV impact scale score ≥ 5

Secondary outcomes

  1. Intraoperative isoflurane consumption

    Time frame: Intraoperative 3 hours

  2. Intraoperative fentanyl consumption

    Time frame: Intraoperative 3 hours

  3. Postoperative 24 hours morphine consumption.

    Time frame: First 24 hours postoperative

    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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Opioid Sparing Anaesthesia Via Dexmedetomidine, Ketamine and Lidocaine Infusion for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2021
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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