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A clinical study to compare two opioid free anaesthesia protocols for paediatric strabismus surgery using ketamine or dexmedetomidine.

Comparison of opioid free anaesthesia protocols for paediatric strabismus surgery: A Randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055878
Enrollment
60
Registered
2023-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: H509- Unspecified strabismus Health Condition 2: H509- Unspecified strabismus

Interventions

Intervention1: Ketamine: Post-induction of anaesthesia, intravenous bolus of ketamine 1mg/kg followed by infusion 1 mg/kg/hr till the end of surgery. Control Intervention1: Dexmedetomidine: Post-indu

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA PS I or II. Posted for elective strabismus surgery.

Exclusion criteria

Exclusion criteria: Parental refusal ASA III or IV Difficult airway Intellectually disabled Heart disease Neurological abnormality H/o motion sickness

Design outcomes

Secondary

MeasureTime frame
To compare the requirement of perioperative fentanyl requirement.Timepoint: From start of surgery till 2 hours after surgery.;To compare the incidence of Oculocardiac Reflex (OCR)Timepoint: From start of surgery till end of surgery.;To compare time to removal of supraglottic device (SGA) from end of sevoflurane.Timepoint: From switching off sevoflurane till LMA removal.;To compare the incidence of Postoperative Nausea & Vomiting (PONV) or Post Operative Vomiting (POV)Timepoint: From extubation till 24 hours post-surgery.;To compare the incidence of Emergence Agitation (EA)Timepoint: From extubation till 24 hours post-surgery. ;To compare the recovery scoresTimepoint: From shifting to PACU till full recovery.;To compare surgeon satisfactionTimepoint: At the end of surgery.;To compare parent satisfactionTimepoint: At the time of discharge.—

Primary

MeasureTime frame
To compare the postoperative pain scores with opioid free anaesthesia protocols with ketamine or dexmedetomidine for paediatric strabismus surgery.Timepoint: End of surgery till 24 hours post-surgery.—

Countries

India

Contacts

Public ContactAditi

All India Institute of Medical Sciences

renusinha@aiims.edu09810305156

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026