Skip to content

A Study to Find Out Whether Low-Dose Dexmedetomidine Works Better Than Fentanyl in Preventing Confusion and Restlessness When Adults Wake Up After General Anaesthesia.

Low dose Dexmedetomidine versus Fentanyl for Attenuation of Emergence Delirium after General Anaesthesia in Adults: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095681
Enrollment
94
Registered
2025-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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: Dexmedetomidine: Patients will be given Fentanyl 1mcg/kg Intravenous bolus plus Dexmedetomidine 0.2mcg/kg/hr intravenous infusion just after induction of anaesthesia till closure of inc

Sponsors

Taba Annu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex 18- 60 years of age American Society of Anaesthesiologists physical status I or II Elective surgery under general anaesthesia Pre-operative MMSE (Mini-Mental state Examination) score more than or equal to 24 BMI less than or equal to 30 kg per m2

Exclusion criteria

Exclusion criteria: Patient s refusal to sign a written informed consent. Severe neurological or psychiatric disorders. Patients on Tranquilizer or antidepressant medication. Patients with history of smoking or alcohol consumption during the last 48 hours. Patients with chronic lung disease. Oto-laryngological procedures (Which poses additional challenges for emergence agitation). Haemodynamically unstable patients. Anticipated difficult airway (Multiple attempts of endotracheal intubation increases emergence delirium).

Design outcomes

Primary

MeasureTime frame
To compare the mean emergence delirium score in the two study groupsTimepoint: Post extubation 20 minutes

Secondary

MeasureTime frame
Time to first rescue analgesiaTimepoint: 1st hour;Extubation timeTimepoint: End of surgery;Postoperative nausea & vomiting (PONV)Timepoint: 1st hour;Emergence timeTimepoint: 1st hour

Countries

India

Contacts

Public ContactL Pradipkumar Singh

Regional Institute of Medical Sciences Imphal Manipur

drlaithangba@gmail.com7005238251

Outcome results

None listed

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