A study comparing standard anesthesia with an opioid-sparing technique to see which helps children recover faster after cleft palate surgery

Comparison of Opioid-Sparing Versus Conventional Opioid-Based Anaesthetic Technique on Recovery Characteristics in Paediatric Patients Undergoing Cleft Palate Repair A Randomised Controlled Trial. - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099001

Enrollment

Registered

2025-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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: Opioid sparing general anaesthesia for cleft palate repair: Use of Injection DEXMEDETOMIDINE 1 mcg per kg intravenous bolus once in preoperative period just before shifting to operatio

Eligibility

Inclusion criteria

Inclusion criteria: ASA Physical Status I or II Age: 6 months to 6 years Sex male and female. Elective, cleft palate repair.

Exclusion criteria

Exclusion criteria: Developmental delay or prematurity Allergy to dexmedetomidine, propofol or lignocaine. Severe cardiac conduction abnormalities Baseline bradycardia [HR less than 50] Severe hypovolemia Advanced heart block Severe ventricular dysfunction

Design outcomes

Primary

Measure	Time frame
The time to first successful oral intake [in mins]Timepoint: In the post op period : From the time of arrival in the post-anaesthesia care unit [PACU] or recovery area.	—

Secondary

Measure	Time frame
Time to Extubation [minutes]Timepoint: the cessation of inhalational anaesthetic agent to successful tracheal extubation (when TOF ratio more than equal to 0.9);WATCHA ScoreTimepoint: post-extubation at 10 mins duration;Intraoperative Hemodynamic Stability [HR & BP]Timepoint: every 5 min intraoperatively;Postoperative Vomiting [POV] EpisodeTimepoint: within the first 4 6 hours postoperatively;FLACC Score [Pain Assessment]Timepoint: be recorded at 0, 30, and 60 minutes postoperatively;Time to First Rescue Analgesia [minutes]:Timepoint: the time from arrival in PACU to the administration of first rescue analgesic	—

Measure

Time frame

Time to Extubation [minutes]Timepoint: the cessation of inhalational anaesthetic agent to successful tracheal extubation (when TOF ratio more than equal to 0.9);WATCHA ScoreTimepoint: post-extubation at 10 mins duration;Intraoperative Hemodynamic Stability [HR & BP]Timepoint: every 5 min intraoperatively;Postoperative Vomiting [POV] EpisodeTimepoint: within the first 4 6 hours postoperatively;FLACC Score [Pain Assessment]Timepoint: be recorded at 0, 30, and 60 minutes postoperatively;Time to First Rescue Analgesia [minutes]:Timepoint: the time from arrival in PACU to the administration of first rescue analgesic

—

Countries

India

Contacts

Public ContactDr Saurav Devale

All India Institute Of Medical Sciences

mriduldhar87@gmail.com9717778374

Outcome results

None listed

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