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A Clinical trial to study the effect of two different muscle relaxant named Cis-Atracurium vs Rocuronium during General Anaesthesia for Laparoscopic Gall Bladder Suregry

Cis-atracurium in different doses vs Rocuronium in Laparoscopic Cholecystectomy Surgery under General Anaesthesia: Prospective, Comparative, Randomised Controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020647
Enrollment
75
Registered
2019-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis

Interventions

Control Intervention1: Cis-Atracurium: C1 group received 0.15 mg/kg of cisatracurium (3Ã?ED 95 of cisatracurium) after induction of anaesthesia .The calculated dose of Muscle Relaxant will be injecte

Sponsors

Central Hospital Garden Reach South Eastern Railway
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologist Physical Status(ASA-PS) I & II 2. Age group 18 --- 60 yrs. 3. Laparoscopic Cholecystectomy surgery under general anaesthesia & Endotracheal intubation with minimum one hour surgery duration (1.00 hrs)

Exclusion criteria

Exclusion criteria: a. ASA class III or IV b. Patients with anticipated difficult intubation (Mallampati score III and more), c. BMI >= 30 d. Patient with diseases affecting neuromuscular transmission (myopathies). e. Patients with severe Cardiovascular, respiratory , renal diseases f. Patients on drug & alcohol abuses. g. Gastroesophageal refiux or hiatus hernia. h. Patients posted for emergency surgery. i. H/o allergy to drugs frequently used in anaesthesia j. Patients receiving medication known to interfere with NMBs (anticonvulsants, amino glycosides or polypeptide antibiotics

Design outcomes

Secondary

MeasureTime frame
1. Haemodynamic changes ( Mean Arterial Pressure, Heart Rate) among the three groups. 2. Any Adverse reaction to drugs (itching, pruritus, anaphylaxis) among the groups . Timepoint: August 2019 to February 2020 i.e. 6 month—

Primary

MeasureTime frame
Comparison of two different doses of cis-atracurium i.e. (3Ã?ED 95) 0.15 mg/kg & (4Ã?ED 95) 0.20 mg/kg vs Rocuronium(3Ã?ED 95) 0.90 mg/kg in (Total 3 groups i.e. CIS 1,CIS 2,ROC) 1. To compare Onset time of the Muscle Relaxant among 3 groups. 2. To compare Time to intubation among 3 groups . 3. To compare Intubating condition among 3 groups . 4. To compare Clinical duration of the Intubating 1st dose or DUR 25 among 3 groups. Timepoint: August 2019 to February 2020 i.e. 6 month—

Countries

India

Contacts

Public ContactDr Samir Basak

Central Hospital ,South Eastern Railway

drsamirbasak@gmail.com9143067142

Outcome results

None listed

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