Study comparing two medicines to control increase in heart rate and blood pressure during breathing tube insertion

Comparison of dexmedetomidine and fentanyl in attenuation of haemodynamic response following laryngoscopy and endotracheal intubation - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092819

Enrollment

144

Registered

2025-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Intravenous dexmedetomidine: Intravenous dexmedetomidine in a dose of 1 mcg/kg in 100 mL normal saline over 10 minutes will be administered prior to induction of general anaesthesia. Co

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients in age group of 18-60 years. 2.American Society of Anesthesiologists (ASA) Status I and II. 3.Patients undergoing laparoscopic cholecystectomy requiring general anaesthesia with endotracheal intubation.

Exclusion criteria

Exclusion criteria: 1. Refusal of patient. 2. Morbid obesity (BMI more than 35 kg/m2). 3. Surgery duration more than 3 hours. 4. Patients at increased risk of aspiration like GERD, peptic ulcer, non-fasting status. 5. Known or anticipated difficult tracheal intubation or facemask ventilation. 6. Cardiorespiratory or cerebrovascular disease. 7. Pregnant or lactating females. 8. Contraindications or allergy to dexmedetomidine and fentanyl. 9. Patient with coagulopathy and bleeding disorder.

Design outcomes

Primary

Measure	Time frame
To study and compare the change in HR, systolic blood pressure (SBP), diastolic blood pressure (DBP), MAP and SpO2 between the two groups of patients during laryngoscopy and endotracheal intubation.Timepoint: Baseline, immediately after intervention, at the time of ETT insertion, at 1 min, 3 min, 5 min, 8 min, 10 min after endotracheal tube insertion.	—

Secondary

Measure	Time frame
1. To study post operative sedation according to Ramsay Sedation Score (RSS). 2. To study adverse effects : Bradycardia, hypotension, nausea, vomiting, respiratory depression. 3. To study haemodynamic parameters in post operative period (Heart rate, diastolic BP, systolic BP, Mean arterial pressure, spO2. Timepoint: Baseline parameters in PACU, at 5 min, 10 ,in, 15 min and 30 min in post operative period.	—

Measure

Time frame

1. To study post operative sedation according to Ramsay Sedation Score (RSS). 2. To study adverse effects : Bradycardia, hypotension, nausea, vomiting, respiratory depression. 3. To study haemodynamic parameters in post operative period (Heart rate, diastolic BP, systolic BP, Mean arterial pressure, spO2. Timepoint: Baseline parameters in PACU, at 5 min, 10 ,in, 15 min and 30 min in post operative period.

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Countries

India

Contacts

Public ContactDr Samriti Sood

Government Medical College and Hospital, Chandigarh

dpkthapa@gmail.com9646121524

Outcome results

None listed

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