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Comparing the combination of Propofol and Remifentanil versus Ketamine for keeping patients calm and comfortable during short gynaecological procedures

COMBINATION OF PROPOFOL WITH REMIFENTANYL Vs KETAMINE INFUSIONS FOR PROCEDURAL SEDATION IN PATIENTS UNDERGOING SHORT GYNAECOLOGICAL SURGERIES A RANDOMISED COMPARATIVE CLINICAL STUDY - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088399
Enrollment
60
Registered
2025-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Remifentanyl: Remifentanyl 50mcg/ml will be given a loading dose of 0.75 mcg/kg over 1 minute followed by infusion of 0.2mcg/kg/min till end of surgery. Control Intervention1: Ketamine:

Sponsors

Institute of medical science and sum hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Females of age group 18-60 years scheduled for short gynaecological surgeries with body mass index less than 35 belonging to ASA 1 or 2.

Exclusion criteria

Exclusion criteria: 1. Patients not giving consent 2. Known allergy or contradiction to either study drugs 3. Psychiatric disorders 4.allergy to egg 5. Hepatic,pulmonary,coronary artery or congenital heart disease 6.severe obesity BMI more than 35 7. Patients belonging toASA greater than 2

Design outcomes

Primary

MeasureTime frame
To compare the total dose of Propofol needed To compare awakening time and postop recovery using the modified aldrete score. To compare sedation using Ramsay sedation score Timepoint: 5 minutes, 10 minutes, 15 minutes, 20 minutes,25 minutes, 30 minutes

Secondary

MeasureTime frame
To compare patient satisfaction in form of pain and awareness. To compare surgeon satisfaction, Cost effectiveness To study side effects and complications hypotension,bradycardia,desaturation,postoperative nausea and vomiting,hallucinations and agitation Timepoint: baseline, 5 minutes, 10 minutes, 15 minutes, 20 minutes,25 minutes, 30 minutes

Countries

India

Contacts

Public ContactAdduri Bhavya Sri Lakshmi

Institute of medical science and sum hospital

daisykaran@soa.ac.in9348417449

Outcome results

None listed

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