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COMPARATIVE STUDY OF KETAMINE-PROPOFOL VS KETAMINE-DEXMEDETOMIDINE IN DAYCARE GYNECOLOGICAL PROCEDURES

COMPARING THE EFFECTIVENESS OF KETAMINE-PROPOFOL VERSUS KETAMINE-DEXMEDETOMIDINE COMBINATION IN PATIENTS UNDERGOING HYSTEROSCOPY AND DILATATION AND CURETTAGE PROCEDURES-A RANDOMISED CONTROLLED TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107441
Enrollment
60
Registered
2026-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified Health Condition 2: O046- Delayed or excessive hemorrhage following (induced) termination of pregnancy Health Condition 3: N921- Excessive and frequent menstruation with irregular cycle Health Condition 4: N924- Excessive bleeding in the premenopausal period Health Condition 5: O02- Other abnormal products of conception Health Condition 6: N950- Postmenopausal bleeding Health Condition 7: O03- Spontaneous abortion Healt

Interventions

Intervention1: Dexmedetomidine and Ketamine combination: Dexmedetomidine 0.5 mcg per kg followed by Ketamine 50 mg IV with Midazolam 1 mg IV and Paracervical Block using 2% Lignocaine Control Interven

Sponsors

NORTHERN RAILWAY CENTRAL HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anaesthesiologists Physical status I and II Aged 18-65 years Posted for hysteroscopy or dilatation and curettage procedures Informed consent obtained

Exclusion criteria

Exclusion criteria: American society of Anaesthesiologists physical status III and above Known allergy to test drugs History of Obstructive sleep apnea Body Mass Index greater than 35 Baseline Oxygen saturation (SPO2) less than 90% Bradycardia (Taken as resting heart rate less than 50 beats per minute to account for individual variations and physiological states) Patient refusal

Design outcomes

Primary

MeasureTime frame
Determine the difference in Recovery Times ( Time taken to reach Ramsay Sedation Score of 1 after drug administration) in Ketofol(ketamine-propofol) and Dexket(Ketamine-Dexmedetomidine) groupsTimepoint: Every 5 minutes intra-operatively and every 15 minutes post operatively till 1 hour

Secondary

MeasureTime frame
1.)To compare the additional Ketamine bolus requirement to maintain RSS(Ramsay Sedation Score) of 4 or BIS 70 in intraoperative period between the two groups 2. To compare pain in both groups using VAS (visual analog scale) scoring 3. To compare changes in hemodynamic parameters in the two groups (Mean Arterial Pressure, Heart Rate) 4. To compare SPO2 changes in the two groups 5. To compare incidence of Post Operative Nausea Vomiting between the two groupsTimepoint: Every 5 minutes intra-operatively & every 15 minutes post operatively till 1 hour

Countries

India

Contacts

Public ContactMAMTA CHADHA

NORTHERN RAILWAY CENTRAL HOSPITAL,NEW DELHI

mamtachadha@rediffmail.com09717630526

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026