Low dose Dexmedetomidine versus Fentanyl for Attenuation of Emergence Delirium after General Anaesthesia in Adults: A Randomized Controlled Trial
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Taba Annu
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- To compare the mean emergence delirium score in the two study groups
Overview
Brief Summary
This study, Low dose Dexmedetomidine versus Fentanyl for attenuation of Emergence Delirium after general anaesthesia in adults: a randomised controlled trial will be undertaken in the Department of Anaesthesiology, RIMS, Imphal, from August 2025 to July 2027. After obtaining institutional ethics committee approval and written informed consents from the patients, 94 patients will be randomized into two groups. Group A patients will be started on Inj. Fentanyl 1mcg per kg IV bolus plus Inj. Dexmedetomidine 0.2 mcg per kg per hr IV infusion. Group B patients will receive a Fentanyl 1 mcg per kg IV bolus plus a Fentanyl 1 mcg per kg per hr infusion following induction of anaesthesia with propofol and maintenance with 50 percent Nitrous oxide in oxygen with Sevoflurane 0.6 to 1.5 percent to titrate the BIS value to 40 – 60 and ETCO2 30-35 mmHg. Infusion drugs will be stopped 15-20 minutes before the end of skin closure and inhalational agents will be cut-off 5-10 minutes before end of skin closure. Reversal of residual neuromuscular blockade will be done when the end tidal anaesthetic agent concentration is less than MAC-Awake. Data will be collected and tabulated in excel format for analysis using SPSS. Data will be analysed using appropriate statistics and a p-value of less than 0.05 will be considered significant
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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
- •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).
- •Anticipated difficult airway (Multiple attempts of endotracheal intubation increases emergence delirium).
Outcomes
Primary Outcomes
To compare the mean emergence delirium score in the two study groups
Time Frame: Post extubation 20 minutes
Secondary Outcomes
- Postoperative nausea & vomiting (PONV)(1st hour)
- Emergence time(1st hour)
- Extubation time(End of surgery)
- Time to first rescue analgesia(1st hour)
Investigators
Taba Annu
Regional Institute of Medical Sciences Imphal Manipur