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Effect of administration of tablet melatonin and tablet clonidine before surgery in reduction of blood pressure and heart rate in response to breathing tube placement in wind pipe for pediatric patients undergoing surgery under general anaesthesia.

Comparison of Oral Melatonin and Oral Clonidine, premedication for attenuation of intubation response in pediatric patients, undergoing surgical procedures under general anaesthesia: A double blinded randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047564
Enrollment
48
Registered
2022-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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: Oral Melatonin: Oral Melatonin 3mg Tablet, given 120 min prior to intubation. Control Intervention1: Oral Clonidine: Oral Clonidine 100 mcg tablet, given 120 min prior to intubation.

Sponsors

AIIMS,RAIPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Weight 15kg to 25kg Surgery planned under general anaesthesia, ASA 1 and 2

Exclusion criteria

Exclusion criteria: -Use of angiotensin-converting enzyme inhibitors (ACE-I), beta blockers, digoxin, a2-agonist . -Bradycardia (heart rate -Mean Arterial blood pressure -Renal (CKD)and hepatic insufficiency. - >2 attempts of Laryngoscopy. -Failed attempts to intubate, converting to LMA insertion. -Patient not giving consent. -History of known allergy to the study drugs. -K/c/o Seizures, Sepsis, Shock, -URTI /LRTI

Design outcomes

Primary

MeasureTime frame
-SBP and DBP -Mean arterial pressure (MAP) -heart rate (HR) will be noted before medication, before induction (baseline), immediately after intubation, at 1,3,5,10 minute after intubation.Timepoint: Before medication, before induction (baseline), immediately after intubation, at 1,3,5,10 minute after intubation.—

Secondary

MeasureTime frame
-MOAA/S( Sedation scale ) -Total Fentanyl used intraoperatively( µg). -Extubation time (in sec) [time between cutting off inhalational agents and tube removal ]Timepoint: Intraoperative period.—

Countries

India

Contacts

Public ContactP A VAIBHAV

AIIMS, RAIPUR

chinmaya.panda06@gmail.com8098007711

Outcome results

None listed

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