Comparing two drugs i.e. Nalbuphine and Dexmedetomidine in attenuating intubation response ( increase in blood pressure and heart rate while inserting endotracheal tube) in patients for surgeries under general anaesthesia.

Not yet recruiting

• Conditions: patients undergoing elective surgery under general anaesthesia

• Registration Number: CTRI/2018/05/013656
• Lead Sponsor: Principal Dr RPGMC Kangra at Tanda

Brief Summary

The present study will be carried out on 60 patient, ASA I,aged between 20-60 yrs, scheduled for surgery under general anaesthesia.The patientwill be randomly divided into two groups. The allocated groups will be labelled  as- Group D (n=30) receiving 1mcg/kg of dexmedetomidine in normal saline (total volume 20ml), Group N(n=30) receiving 0.2mg/kgof nalbuphine in normal saline (total volume 20 ml).

The effect of nalbuphine and dexmedetomidine will be studied in two groups at intubation for the changes in haemodynamic parameters- pulse rate,systolic blood pressure,diastolic blood pressure,mean arterial pressure and oxygen saturation. Also sedation will be evaluated using Ramsay Sedation Score. The patients will also be closely monitored for any side effects in form of post operative nausea, vomiting and bradycardia.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-02-05
• Study Start: 2018-09-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Male and female patients undergoing elective surgeries under general anaesthesia.
• 2.Amercian society of Anesthesiologist physical status I-II.
• 3.BMI between 18.5-29.9 Kg/m2.

Exclusion Criteria

• 1.Age <20yrs and >60yrs.
• 2.ASA grade 3 and 4.
• 3.History of allergy to any of study drugs.
• 4.Patients with peri-operative heart rate < 55bpm and/or Systolic BP < 90mmHg. 5.Patients receiving other alpha 2 agonists like clonidine or other opioid.
• 6.Patients noted to have dysrhythmias on the electrocardiogram (ECG).
• 7.Unwilling patients.
• 8.Patients who are opioid tolerant or opioid dependent.
• 9.Pregnant women.
• 10.Anticipated difficult intubation.
• 11.Patient with cardiac, pulmonary, neurologic, kidney diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the changes in HR and BP after laryngoscopy and intubation.	Haemodynamic response every 1 min till 5 min and there onwards at 10 min,20 min,30 min

Secondary Outcome Measures

Name	Time	Method
To study and compare PONV and sedation score.	To observe for side effects of any of study drugs, if any.

Trial Locations

Locations (1)

Department of Anaesthesia; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Department of Anaesthesia

🇮🇳Kangra, HIMACHAL PRADESH, India

Vishal Vashist

Principal investigator

9418115612

vishalvashist1986@gmail.com