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

Combination of haloperidol & ondansetron is non inferior to dexamethasone & ondansetron for prevention of post operative nausea and vomiting in patients undergoing laparoscopic gynaecological procedures. A randomised double blinded trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056860

Enrollment

116

Registered

2023-08-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system

Interventions

Intervention1: Haloperidol & Ondansetron: Haloperidol 1mg given after induction, Ondansetron 8mg given 30 minutes prior to extubation. Control Intervention1: Dexamethasone & Ondansetron: Dexamethasone

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I/II Scheduled for laparoscopic procedures >1hr duration

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
Incidence of nausea using 11 point verbal numerical rating scale & number of episodes of vomiting Timepoint: First 24 hours following laparoscopic gynaecological procedure	—

Secondary

Measure	Time frame
corrected QT intervalTimepoint: within first hour following laparoscopic gynaecological procedure;Extent of sedationTimepoint: First 24 hours following laparoscopic gynaecological procedure, using Observers assessment of alertness/sedation scale;Incidence of delirium using confusion assessment method (CAM)Timepoint: First 24 hours following laparoscopic gynaecological procedure;Post operative analgesiaTimepoint: First 24 hours following laparoscopic gynaecological procedure, using Visual Analog Score (VAS);Requirement of rescue antiemeticTimepoint: First 24 hours following laparoscopic gynaecological procedure, & name of drug administered;Time to administration of rescue antiemeticTimepoint: from end of procedure to occurrence of first episode of vomiting or sensation of nausea	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactAnantha Savithri

Post Graduate Institute of Medical Education and Research

karansingla16@gmail.com9592919073

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026