To compare the effect of drugs ketofol and ketodex during oocyte pickup in in-vitro fertilisation procedures.

Comparison of the effect of ketofol and ketodex as procedural sedation and analgesia for oocyte retrieval during in-vitro fertilisation procedures- a randomised controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/047865

Enrollment

Registered

2022-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: Z30-Z39- Persons encountering health services in circumstances related to reproduction

Interventions

Intervention1: GROUP KD (KETODEX-KETAMINE AND DEXMEDETOMIDINE): Group KD will receive loading dose of dexmedetomidine 1mcg/kg for 10 minutes and bolus dose of Ketamine 0.5mg/kg for 2-3 minutes for ind

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 20 to 40 years 2.ASA grade I -II patients scheduled for oocyte retrieval

Exclusion criteria

Exclusion criteria: 1.Refusal for Consent 2.BMI >30 3.ASA grade III-IV Patients 4.Allergy to any of the study drugs 5.Patients with documented autonomic dysfunction 6.Uncontrolled systemic illness 7.Chronic diseases (Liver and kidney diseases, cancer, infectious diseases and autoimmune conditions)

Design outcomes

Primary

Measure	Time frame
To calculate mean pain scores intra-operatively and in the first 2 hours post-oocyte retrieval.Timepoint: To calculate mean pain scores intra-operatively and in the first 2 hours post-oocyte retrieval.	—

Secondary

Measure	Time frame
1)Intra and postoperative hemodynamic parameters will be noted. 2)Intra and postoperative assessment of sedation level. 3)Number of patients having moderate to severe pain at 30 minutes, 1 and 2 hours post-operatively. 4)Total dose of intraoperative rescue bolus and postoperative rescue analgesia required. 5)Duration of procedure and time till discharge will be calculated. 6)To assess the incidence of PONV and other complications. 7)Fertilisation rate 8)Cleavage rateTimepoint: 1)Intra and postoperative hemodynamic parameters will be noted. 2)Intra and postoperative assessment of sedation level. 3)Number of patients having moderate to severe pain at 30 minutes, 1 and 2 hours post-operatively. 4)Duration of procedure and time till discharge will be calculated.	—

Measure

Time frame

1)Intra and postoperative hemodynamic parameters will be noted. 2)Intra and postoperative assessment of sedation level. 3)Number of patients having moderate to severe pain at 30 minutes, 1 and 2 hours post-operatively. 4)Total dose of intraoperative rescue bolus and postoperative rescue analgesia required. 5)Duration of procedure and time till discharge will be calculated. 6)To assess the incidence of PONV and other complications. 7)Fertilisation rate 8)Cleavage rateTimepoint: 1)Intra and postoperative hemodynamic parameters will be noted. 2)Intra and postoperative assessment of sedation level. 3)Number of patients having moderate to severe pain at 30 minutes, 1 and 2 hours post-operatively. 4)Duration of procedure and time till discharge will be calculated.

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Countries

India

Contacts

Public ContactDr Sainath Veeranki

All India Institute of Medical sciences New Delhi

drshail.kumar@gmail.com8745027472

Outcome results

None listed

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