Patients Undergoing Laparoscopic Surgery Clinical Trial
Official title:
Efficacy of Atracurium-vecuronium Combination in Patients Undergoing Laparoscopic Surgery:a Randomised Controlled Study
Non-depolarising muscle relaxants are routinely employed to provide skeletal muscle relaxation during general anaesthesia (GA). Generally investigators use one or the other type of relaxant agent for this purpose and they are categorised based on their duration-of-action. Atracurium and vecuronium are two common muscle relaxant used during GA. They have an intermediate duration of action (around 40 minutes). Though they are effective relaxants and easy to reverse with reversal agents after the surgery, in case of the common laparoscopy procedures lasting an hour, they are relatively inefficient. There is evidence that when these agents are combined together (in 1:1 ratio), the duration-of-action, and reversibility improves. To render atracurium and vecuronium more efficient with laparoscopic surgery, the proposed study is aimed to evaluate the effects of combining 1/2 the respective standard doses of atracurium and vecuronium given together, in terms of its effect on the onset of block, duration-of-action, and reversibility of the neuromuscular blockade in adults undergoing laparoscopic surgery under GA. The study will be conducted with objective assessment parameter evaluation by TOF Watch SX (Organon, Teknica BV, Boxtel, The Netherlands), which will be used for facilitating institution, control, and monitoring the neuromuscular blockade during surgery. The objective of this study is to evaluate the additive effect of atracurium-vecuronium combination and profile its impact in patients undergoing laparoscopic surgery, especially in terms of increase in duration-of-action of muscle relaxation with the combination of drugs, when compared to respective individual drugs.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | October 25, 2018 |
Est. primary completion date | October 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. ASA physical status I and II 2. Laparoscopic surgeries likely to last for 1 hour duration Exclusion Criteria: 1. Patient refusal 2. ASA physical status III and IV 3. History of hypersensitivity to atracurium or vecuronium 4. Alcoholism and drug addiction 5. Neuromuscular disorders 6. Neuropsychiatric patients 7. Hepatic and renal disease patients 8. Obese patients 9. Abnormal airway anatomy 10. Risk of oesophageal reflux |
Country | Name | City | State |
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India | Sir Ganga Ram Hospital | New Delhi | Delhi |
Lead Sponsor | Collaborator |
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Sir Ganga Ram Hospital |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration-of-action of the intubating dose | Duration of action will be calculated from the time the drug is administered till theTOF count is 1 on the accelerometer. | From the time of administration of (0-hours, baseline) till 60-minutes intraoperatively | |
Secondary | Onset-of-action of muscle relaxation following intubating dose | Onset-of-action will be calculated from the time the drug is administered till theTOF count is 0 on the accelerometer. | From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively | |
Secondary | Qualitative intubating conditions. | Quality of intubating condition will be assessed using 3-point modified Cooper's scale. The intubating conditions will be graded as excellent, good & poor. The scale "Intubating conditions following intubating dose of non-depolarizing muscle relaxant" is modified from Cooper's Scale. The scale's name is derived from the name of the investigator (Cooper R) who first used it. (Br J Anaesth 1992; 69: 269-73) The Cooper Scale includes five major variable sets [1. Laryngoscopy (Jaw Relaxation), 2.Vocal-cord position, 3. Vocal cord movement, 4. Reaction to intubation and/or cuff inflation 5. Movement of limbs/ coughing] which are classified as poor, good or excellent. For ease of the study analysis, poor is scored '0', good is scored '1', and excellent is scored '2'. Therefore, each variable has subscale range of 0-2 and, five variables are together ranged as 0-10. Each of the five subscale range, i. e. 0-2, are added up to gain a 'total scale range score' of 0-10. |
From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively | |
Secondary | Reversibility of muscle relaxant effect | Time for complete reversal of effect of muscle relaxation will be determined from the time of administration of reversal agent till the the point when TOF ratio is 90-percent. | From the time of administration of (0-hours, baseline) till 5-minutes post administration |
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