A clinical trial to study the effect of two drugs, rocuronium and cisatracurium in adults subjected to general anaesthesia.
- Conditions
- All adults undergoing elective surgeries under general anaesthesia
- Registration Number
- CTRI/2018/05/014201
- Lead Sponsor
- Dr Paramanand Reddy
- Brief Summary
The first successful administration of a neuromuscular blocker (curare) to produce surgical relaxation in an anaesthetized patient occurred in 1912, when Arthur Lawen, a German surgeon from Leipzig, used a partially purified preparation of the substance. Since their introduction, muscle relaxants have become a part and parcel of every anaesthesiologist’s routine practice.These agents aid not only in endotracheal intubations and mechanical ventilation but also decrease anaesthetic requirement, patient movement and oxygen consumption. Newer and novel addition to this drug arsenal are cisatracurium and rocuronium.
Cisatracurium is a new intermediate duration, non-depolarizing, benzylisoquinolinium neuromuscular blocking drug which is a stereoisomer of atracurium. It exhibits stable cardiovascular profile and organ dependent Hoffman elimination. Cisatracurium does not trigger histamine release and the adult ED95 is 0.05mg/kg.
Rocuronium which is also an intermediate duration drug, is an aminosteroidal non depolarizing neuromuscular blocker and analogue of vecuronium. As with cisatracurium, even rocuronium doesn’t trigger histamine release and the adult ED95 is 0.3mg/kg.
Given the fact that both drugs exhibit a good safety profile, we are interested to know whether the standard induction doses could be exceeded to provide more favourable conditions for intubation. Also, studying the onset and duration of action of a single intubating dose is on the agenda. As there are not many Indian studies comparing cisatracurium and rocuronium, the present study will serve as a pedestal for any such new studies in India. Our study also aims at comparing the neuromuscular blocking and hemodynamic effects of the above drugs, thus helping in choosing the desirable drug when in a dilemma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 90
- Patients posted for elective surgeries under general anaesthesia 2) ASA 1 and 2 3) Mallampatti grade 1 and 2 4) Surgery with duration more than 30 minute.
- Restricted arm positions or likely changes in arm position during surgery 2) Patients who require rapid sequence intubation 3) Patients undergoing laparoscopic surgeries 4) Patients on aminoglycoside therapy or those who may need it intraoperatively.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)Hemodynamic variables(Heart rate; systolic, diastolic and mean arterial pressure) will be recorded at successive intervals like T0, T1, T2, T3, T4, T5, T6, T7, T8 and Tn. T0-Before induction. | T1-After induction. | T2-After injection of neuromuscular blocker. | T3-Just after intubation. | T4, T5, T6, T7, T8-At a successive interval of 2min each after T3. | Tn-At a successive interval of 10min each after T8. b) Intubating conditions assessed and graded based on ease of passage of tube with or without coughing/bucking and vocal cord position. T0-Before induction. | T1-After induction. | T2-After injection of neuromuscular blocker. | T3-Just after intubation. | T4, T5, T6, T7, T8-At a successive interval of 2min each after T3. | Tn-At a successive interval of 10min each after T8.
- Secondary Outcome Measures
Name Time Method a) onset time of neuromuscular blockade b) clinical duration of neuromuscular blockade
Trial Locations
- Locations (1)
Father Muller Medical College
🇮🇳Kannada, KARNATAKA, India
Father Muller Medical College🇮🇳Kannada, KARNATAKA, IndiaDr Paramanand ReddyPrincipal investigator7411417045drpreddy92@gmail.com