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

Tanta University

Status and phase: Completed; Phase 4

Conditions: PONV; Opioid Sparing Anaesthesia

Treatments: Drug: Normal saline; Drug: Dexmedetomidine, ketamine and lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04706897

33362/9/19

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Normal saline (Control) group

Sham Comparator group

Description:

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).

Treatment:

Drug: Normal saline

Dexmedetomidine, ketamine and lidocaine (Study) group

Experimental group

Description:

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).

Treatment:

Drug: Dexmedetomidine, ketamine and lidocaine