Evaluation of Pentazocine Premedication with Ketamine Propofol Sedation During Short Gynecological Procedures

Efficacy of Pentazocine Premedication for Optimizing Ketamine Propofol Sedation During Short Gynecological Procedures: A Three Arm, Triple Blind Randomized Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260913005

Enrollment

Registered

2026-09-13

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-10-05

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

Conditions

Adult female undergoing short gynecologic procedures under sedation. We will study procedural pain and intraoperative patient movement during minor gynecological surgery under conscious/deep sedation. Deep Sedation Analgesia Pentazocine Ketamine Ketofol

Interventions

Participants receive 5 mL of intravenous Normal Saline over 30 seconds as premedication along with intravenous Midazolam 1 mg and Paracetamol 1 g, 10 minutes prior to induction. Induction is performed

Active Comparator Drug,Experimental Drug,Experimental Drug

Normal Saline Vehicle Control Premedication with Standard Ketamine Propofol Sedation,Low-Dose Pentazocine (0.25 mg/kg) Premedication with Ketamine Propofol Sedation,High-Dose Pentazocine (0.5 mg/kg) P

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult female patients aged 18 to 65 years, 2. American Society of Anesthesiologists (ASA) physical status I or II, 3. Scheduled for elective short gynecological procedures with an operative duration less than 30 minutes.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate or give informed consent; 2. Known allergy or hypersensitivity to any study drug; 3. History of opioid dependence or chronic pain conditions; 4. Pregnancy; 5. Significant hepatic, renal, or cardiovascular disease; 6. ASA physical status III or above; 7. Cognitive dysfunction, psychiatric or neurological disorder, or inability to report pain scores reliably; 8. Obesity (Body mass index >35 kilogram per meter square).

Design outcomes

Primary

Measure	Time frame
Incidence of significant intraoperative patient movement requiring rescue sedation during procedure During surgical procedure after starting sedation Incidence of movement	—

Secondary

Measure	Time frame
Time to Target Sedation Depth From induction initiation until attainment of target sedation score Measured in seconds from start of ketamine propofol induction to loss of verbal response and achievement of target sedation,Intraoperative Hemodynamic Parameters Baseline, every 2 to 3 minutes intraoperatively up to 30 minutes, and upon completion of the procedure. Recorded values for Heart Rate (bpm via continuous 5-lead ECG), Systolic and Diastolic Blood Pressure, Mean Arterial Pressure (mmHg via automated NIBP every 3 minutes), and Pulse Oximetry	—

Measure

Time frame

Time to Target Sedation Depth From induction initiation until attainment of target sedation score Measured in seconds from start of ketamine propofol induction to loss of verbal response and achievement of target sedation,Intraoperative Hemodynamic Parameters Baseline, every 2 to 3 minutes intraoperatively up to 30 minutes, and upon completion of the procedure. Recorded values for Heart Rate (bpm via continuous 5-lead ECG), Systolic and Diastolic Blood Pressure, Mean Arterial Pressure (mmHg via automated NIBP every 3 minutes), and Pulse Oximetry

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Countries

India

Contacts

Public ContactKumari Singh

Tata Main Hospital, Jamshedpur

kumari.singh@tatasteel.com00919430742001

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Oct 17, 2026