Comparison of characteristics of Cisatracurium drug with different doses in elderly patients undergoing general anaesthesia.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/10/046472
• Lead Sponsor: Department of anaesthesiology

Brief Summary

AIM

To compare neuromuscular blocking characteristics of cisatracurium with and without its priming dose in elderly patients undergoing General Anaesthesia.



PRIMARY OBJECTIVE :- To compare the effect on time of onset of action of cisatracurium given with and without its priming dose in elderly patients undergoing General Anaesthesia.



SECONDARY OBJECTIVES :-

1.) To compare the effect on the time to complete block of cisatracurium given with and without its priming dose in elderly patients undergoing General Anaesthesia.

2.) To compare hemodynamic parameters and side effect profile in patients of two groups.



METHOD OF RANDOMIZATION

60 ASA grade I and II patients will be divided into two groups 1 and 2 by using computer generated random number table.

GROUP 1 (n= 30) : Patients will receive Priming Dose of Inj. Cisatracurium at dose of 0.015 mg/kg. GROUP 2 (n=30) : Patients will receive Normal Saline 5 ml.



METHOD OF PREPARING PRIMING DOSE :-

Group 1 (n=30) will receive priming dose of injection cisatracurium IV (dose as per weight) & will dilute it with Normal Saline to make 5 ml.

Group 2 (n=30) will receive Normal Saline 5 ml.



METHOD OF GIVING GENERAL ANESTHESIA

A preanesthetic evaluation will be done for all the cases.

Written and Informed Consent will be taken.

All patients will be kept fasting for 8 hours night before surgery.

In OT , multipara monitors will be attached to record ECG, Non-invasive blood pressure (NIBP), SpO2 , End-tidal Carbon dioxide (Et CO2) and temperature.

Baseline parameters will be recorded for all patients.

IV access will be established.

Neuromuscular monitoring apparatus will be attached to the patient.

NMT apparatus will be set to TOF with supramaximal stimulus at 0.05 Hz and frequency at 20 seconds.

Patient will be pre-oxygenated with 100% O2 for 3 minutes using appropriate size face mask. Patients will receive Inj. Midazolam 0.03 mg/ kg IV, Inj. Fentanyl 2 mcg /kg IV

Priming dose will be given in group 1 as 0.015 mg/kg in Normal Saline to make 5 ml solution and 5 ml Normal Saline only will be given in group 2.

We will wait for 3 minutes after giving priming dose and before starting induction of anaesthesia.



METHOD OF ONSET OF ACTION :

Time of onset will be noted when TOF count is 2/4



METHOD OF KNOWING COMPLETE BLOCK :

Time to complete block will be noted when TOF count is 0/4

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-13
• Study Start: 2022-10-25

Recruitment & Eligibility

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

Inclusion Criteria

BMI 18-30, ASA grade 1&2, Modified Mallampati grade 1&2.

Exclusion Criteria

Patients with anticipated difficult airway, uncontrolled DM, uncontrolled hypertension, untreated CAD, post CVA, extremes of weight, uncontrolled asthma, neuromuscular disorders, history of atopy, active copd, patients on antibiotics, known history of allergy to Cisatracurium.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to onset of neuromuscular block.	Time at which TOF count is 2/4

Secondary Outcome Measures

Name	Time	Method
Time to complete block.	Time at which TOF count is 4/4

Trial Locations

Locations (1)

Dr. RML Hospital; 🇮🇳 Central, DELHI, India

Dr. RML Hospital

🇮🇳Central, DELHI, India

Vijay Kumar Nagpal

Principal investigator

9968304240

nagpalvijaykumar@gmail.com