Time taken to emerge from anaesthesia after dexmedetomidine or ketamine when used with propofol for anaesthesia in children undergoing urethral surgery

Randomised controlled study to compare time to postoperative recovery after opioid free total intravenous anaesthesia using propofol either with ketamine or dexmedetomidine in children undergoing urethroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053761

Enrollment

Registered

2023-06-12

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: N36- Other disorders of urethra

Interventions

Intervention1: Ketamine with propofol: Ketamine@ 1mg/kg over 10 minutes (body weight of the patient over 10min). This will be followed by flash induction of anaesthesia with propofol set at a target

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patients in the age group of 3-11yrs 2. ASA I and ASA II 3. Undergoing urethroplasty of duration 1-4 hours

Exclusion criteria

Exclusion criteria: 1.Any known allergy to drugs used in the study 2.Patients with language barrier/ mental retardation/ unable to communicate 3.Indication for use of opioids during surgery.

Design outcomes

Primary

Measure	Time frame
Comparison of time taken (in minutes) to achieve modified Aldrete score of â?¥ 9 [Mean Â± SD or median (IQR)] using propofol either with ketamine or dexmedetomidine in children undergoing urethroplasty.Timepoint: Immediate postoperative period	—

Secondary

Measure	Time frame
Comparison between the groups 1.Mean plasma concentration of propofol (Âµg/ml) 2.Mean propofol requirement (Âµg/kg /min) 3. Mean difference between awake time predicted by the TCI pump & actual awake time 4. Mean total 24 hours post-operative analgesic requirement 5. Proportion of patients with occurrence of post-operative nausea & vomiting, irrelevant talk, hallucination, occurrence of explicit recall and haemodynamic complications (bradycardia, tachycardia, hypotension and hypertension)Timepoint: 1.Immediate postoperative period 2.Immediate postoperative period 3. Immediate postoperative period 4. 24 hours 5. 24 hours	—

Measure

Time frame

Comparison between the groups 1.Mean plasma concentration of propofol (Âµg/ml) 2.Mean propofol requirement (Âµg/kg /min) 3. Mean difference between awake time predicted by the TCI pump & actual awake time 4. Mean total 24 hours post-operative analgesic requirement 5. Proportion of patients with occurrence of post-operative nausea & vomiting, irrelevant talk, hallucination, occurrence of explicit recall and haemodynamic complications (bradycardia, tachycardia, hypotension and hypertension)Timepoint: 1.Immediate postoperative period 2.Immediate postoperative period 3. Immediate postoperative period 4. 24 hours 5. 24 hours

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Countries

India

Contacts

Public ContactDr Shweta Saini

Lady Hardinge Mecical College and associated Hospitals

maitreepandey@gmail.com

Outcome results

None listed

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