A Prospective Randomized Clinical Trail of Three Different Doses of Rocuronium Bromide for Intubation in Adults

Manoharan, T (2010) A Prospective Randomized Clinical Trail of Three Different Doses of Rocuronium Bromide for Intubation in Adults. Masters thesis, Chengalpattu Medical College, Chengalpattu.

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Abstract

INTRODUCTION: In the triad of anaesthesia, reflex suppression and facilitation of tracheal intubation is achieved by administering neuromuscular blocking agents. An ideal muscle relaxant should have rapid onset, profound muscle relaxation and short duration of action, so that patient’s own respiratory function can be restored, should intubation proved to be impossible. Succinylcholine is the only available muscle relaxant for rapid tracheal intubation. Its use is associated with multiple complications like bradycardia, hyperkalemia, asystole, raised intraocular pressure, malignant hyperthermia, etc. Therefore need exists for a nondepolarizing muscle relaxant with a rapid onset of action. Rocuronium bromide is a new steroidal nondepolarizing neuromuscular blocking agent shown to have rapid onset of action. It has the fastest onset as compared to all other available nondepolarizing neuromuscular blockers, having an onset time similar to succinylcholine. The onset time, duration and intubating conditions are influenced by the dose of rocuronium. AIM OF THE STUDY: This study is aimed at comparing intubating conditions in 80 seconds by using three different doses of rocuronium bromide in adults by assessing the following parameters: 1. The onset time and duration of neuromuscular blockade, 2. Intubating conditions and, 3. Haemodynamic changes. MATERIALS AND METHODS: This study was conducted in 60 patients who met the study criteria and underwent general anaesthesia with endotracheal intubation. Design of Study: It is a Comparative Prospective Randomized clinical trial study. The study was approved by the Ethical Committe and done during the period from May 2009 to August 2009 in the Department of Anaesthesiology, Chengalpattu Medical Mollege Hospital, Chengalpattu. The surgeon was also duly informed of the study. The inclusion criteria were: 1. Patients of ASA grade I and II of either sex, 2. MPC I and II, 3. Age group of 25 to 45 years, 4. Elective surgeries posted under G.A. The exclusion criteria were : 1.Known or anticipated difficult airways, 2.Patients with neuromuscular disease, 3.Drugs known to interact with neuromuscular blocking agents, 4.Family H/O Malignant Hyperthermia, 5.Renal or Hepatic disorder, 6.Known allergy to drugs. Sixty patients who fulfilled the eligibility criteria were enrolled for the study. Preoperatively informed, written consent was obtained from these patients. These patients were systematically randomized into three groups of twenty each. Group 1 - Thiopentone 5mg/kg + Rocuronium 0.6 mg/kg, Group 2 - Thiopentone 5mg/kg + Rocuronium 0.9 mg/kg, Group 3 - Thiopentone 5mg/kg + Rocuronium 1.2 mg/kg, Statistical Evaluation: All recorded data were entered using MS Excel software and analyzed using STATA software for determining the statistical significance. Analysis of Variance (ANOVA) was used to study the significance of mean of various study parameters among the three groups. Student’s ‛t’ test was used to compare the two groups on mean values of various parameters. The p-value taken for significance is 0.05. RESULTS: 1. Statistical analysis showed that there was significant difference between distribution of age and sex among the three study groups (Table IV). 2. Jaw relaxation: On analyzing the jaw relaxation, it was impossible to open in one case and open with difficulty in six cases in Group 1. These kind of problems did not occur in Group 2 & Group 3 (Table V). Statistical analysis showed that the mean score for jaw relaxation was significantly higher in Group 2 & Group 3 (ie; 2.7± 0.47, 2.7 ± 0.47) than Group 1 (ie; 1.7± 0.73). 3. Vocal cod position : Regarding vocal cord position ,the closed status (score 0) was seen in three cases in Group 1 whereas no such case had been encountered in Group 2 & Group 3 (Table VI). Mean score for vocal cord position was significantly higher in Group 2 & Group 3 when compared to Group 1 (1.5 ±0.94, 2.65 ± 0.58, 2.7 ± 0.57 in Group 1, 2 & 3 respectively). 4. Response to intubation : With regard to response to intubation, two cases had severe coughing /bucking and seven cases had mild coughing in Group 1. These untoward events did not happen in Group 2 & Group 3 (Table VII). Mean score for response to intubation was significantly higher in Group 2 & Group 3 when compared to Group 1 (1.55 ± 0.82, 2.75 ± 0.44, 2.8 ± 0.41 in Group 1,2 & 3 respectively). 5. Intubation score : The analysis of intubation scores to assess conditions at intubation shows that higher doses result in a statistically significant increase in the ease of intubation. Mean total intubating score in Group 2 & Group 3 were identical which is significantly higher than Group 1 (4.75± 2.19, 8.1 ± 1.16, 8.2 ± 1.15 in Group 1, 2 & 3 respectively). 6. Acceptable intubating conditions (excellent and good scores) were observed in 19 patients in Group 2 and Group 3. 4 patients had poor intubation score and 7 patients had fair intubation score in Group 1. No significant differences in intubating conditions between rocuronium 0.9mg/kg and 1.2mg/kg. 7. Statistical analysis revealed that mean Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure during intubation in Group 1 was significantly higher than in Group 2 and Group 3.(108 ± 11, 135.1 ± 8.7, 85.45 ± 8.9, 98.45 ± 12.1 in Group1, 96.4 ± 12.9 ,123.4 ± 4.8, 79.05 ± 6.5, 92.4 ± 6.9 in Group 2 & 99.15 ± 10.3, 126.05 ± 7, 77.9 ± 5.6, 92.45 ± 6.0 in Group 3 respectively (Tables VIII, IX, X, XI). 8. Mean Heart Rate at the end of 5 minutes was higher in Group 1 compared to Group 2 and Group 3.(99.9 ± 11.2, 86.4 ± 10.3 , 85.65 ± 6.4 in Group, 2 and 3 respectively). 9. The analysis showed that the onset of blockade is inversely proportional to the dose of rocuronium. The onset time for the intubating dose was significantly lower in Group 3 and between Group 1 & 2, the onset time was significantly lower in Group 2 (102.25 ± 29.93sec in Group 1, 70 ± 20.13 sec in Group 2 and 61.2 ± 12.95 sec in Group 3). 10. The duration of neuromuscular blockade increases as the dose increases. Duration of action of the intubating dose was significantly higher in Group 3 when compared to Group 1 & 2. (25.5 ± 3.59 minutes in Group 1, 39.75 ± 4.43 minutes in Group 2 and 57.25 ± 7.51 minutes in Group 3) (Table XII). CONCLUSION: Among the three doses of rocuronium bromide used for endotracheal intubation in the study, I conclude that, rocuronium bromide in the dose of 0.9mg/kg (Group 2) produced acceptable intubating conditions in 80 seconds without undue prolongation of the neuromuscular blockade.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Three Different Doses ; Rocuronium Bromide ; Intubation ; Adults ; Prospective Randomized Clinical Trail.
Subjects: MEDICAL > Anaesthesiology
Depositing User: Subramani R
Date Deposited: 30 Apr 2018 03:20
Last Modified: 30 Apr 2018 03:20
URI: http://repository-tnmgrmu.ac.in/id/eprint/7353

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