Comparison between two groups of drugs for prevention of nausea & vomiting in women after surgery on uterus or ovaries.

Phase 3

Not yet recruiting

• Conditions: Other intraoperative and postprocedural complications and disorders of genitourinary system,

• Registration Number: CTRI/2023/08/056860
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

The study aims to compare two drug combinations for prophylaxis of post operative nausea and vomiting in patients undergoing laparoscopic gynaecological procedures.

Group DO: will receive 8mg dexamethasone after induction and 8mg ondansetron 30 minutes prior to extubation.

Group HO: will receive 1mg haloperidol after induction and 8mg ondansetron 30 minutes prior to extubation.



Primary outcome assessed will be the incidence of nausea and number of episodes of vomiting in the first 24 hours following the procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-09
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 116

Inclusion Criteria

ASA physical status I/II Scheduled for laparoscopic procedures >1hr duration.

Exclusion Criteria

• History of hypersensitivity or allergic reaction to ondansetron or haloperidol 2.
• Established diagnosis or family history of congenital long QT syndrome 3.
• Parkinsons disease 4.
• Use of anti emetic within 24 hours of surgery 5.
• Use of antipsychotic drugs 6.
• Pregnant patients 7.
• Obese patients (BMI >30) 8.
• Electrolyte abnormalities 9.
• Haemodynamic instability in the peri operative period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of nausea using 11 point verbal numerical rating scale & number of episodes of vomiting	First 24 hours following laparoscopic gynaecological procedure

Secondary Outcome Measures

Name	Time	Method
Requirement of rescue antiemetic	First 24 hours following laparoscopic gynaecological procedure, & name of drug administered
Post operative analgesia	First 24 hours following laparoscopic gynaecological procedure, using Visual Analog Score (VAS)
Extent of sedation	First 24 hours following laparoscopic gynaecological procedure, using Observers assessment of alertness/sedation scale
Incidence of delirium using confusion assessment method (CAM)	First 24 hours following laparoscopic gynaecological procedure
Time to administration of rescue antiemetic	from end of procedure to occurrence of first episode of vomiting or sensation of nausea
corrected QT interval	within first hour following laparoscopic gynaecological procedure

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Dr Anantha Savithri

Principal investigator

9538680995

savithri1610@gmail.com