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Comparison of opioid free anesthesia with opioid based anesthesia in neonates and infants undergoing laparoscopic or endoscopic surgeries

Comparison of opioid free anesthesia with opioid based anesthesia in neonates and infants undergoing laparoscopic or endoscopic surgeries : A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042794
Enrollment
96
Registered
2022-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: P00-P96- Certain conditions originating in the perinatal period Health Condition 2: A00-B99- Certain infectious and parasitic diseases Health Condition 3: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities Health Condition 4: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism Health Condition 5: K00-K95- Diseases of the digestive system Health Condition 6: N00-N99- Diseases of the genito

Interventions

Intervention1: ketamine and paracetamol: Infant will receive opioid free anesthesia that is Ketamine bolus of 0.5 mg per kg at induction followed by infusion of 0.2 mg per kg per hr and Paracetamol 10

Sponsors

Department of Anesthesiology and critical care aiims jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates and infants with ASA 1 and 2 undergoing laparoscopic or endoscopic surgeries

Exclusion criteria

Exclusion criteria: 1. Refusal of informed parental consent 2. Patient with prior hypersensitivity to the drug 3. Patient with clinical hypertension 4. Requirement of postoperative mechanical ventilation 5. Patient undergoing cardiac or thoracic surgeries

Design outcomes

Primary

MeasureTime frame
To compare postoperative pain in post anesthesia care unit between opioid based and opioid free anesthesiaTimepoint: arrival to post anesthetic care unit and at 30 minute, 1 hour, 2 hour, 6 hour, and 12 hour

Secondary

MeasureTime frame
To compare postoperative pain scores at 30 minute 1 hour 2 hour 6 hour and 12 hour To compare the time of 1st postoperative rescue analgesic requirement To compare time of extubation from stopping study drug infusion To compare intraoperative haemodynamic stability To compare the duration of PACU stay To compare the incidence of any side effect Timepoint: pain scores at 30 minute 1 hour 2 hour 6 hour and 12 hour

Countries

India

Contacts

Public ContactL Pfokreni

Aiims Jodphur

pk_bhatia@yahoo.com9829159665

Outcome results

None listed

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