Rocuronium Consumption in Etomidate-based and Propofol-based General Anesthesia Under Sevoflurane

Study Overview
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Brief Summary
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Different concentration of sevoflurane was given to maintain anesthesia. The dose of propofol to maintain BIS between 40-60 and the consumption of rocuronium was recorded and evaluated.

Detailed Description
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2 age group of patients was selected, 40-60 years and above 60 years. Maintenance of anesthesia was carried out using different concentration of Sevoflurane, ie MAC 0.5, 0.75 and 1.0. Bis value was kept between 40-60 and the dose of propofol required was recorded. Rocuronium infusion given in a close loop infusion system for different group was tabulated. The results was then analysed.

Official Title
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Consumption of Rocuronium Under Etomidate-based Versus Propofol-based Maintenance of General Anesthesia Under Different Concentration of Sevoflurane- BIS Guided Clinical Trial in a Closed Loop Infusion System

Conditions
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Neuromuscular Monitoring

Intervention / Treatment
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* Drug: MAC 0.5
* Drug: MAC 0.75
* Drug: MAC 1.0
* Drug: Propofol
* Drug: Etomidate
* Drug: Rocuronium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI < 30 elective Gynaecological/abdominal/urological surgery Operation time < 3hrs ASA I/II Intubated patients Exclusion Criteria: Coronary artery disease, cardiac, lung, hepatic and renal insufficiency Severe uncontrolled HBP Obesity (BMI >30) Neuromuscular and metabolic diseases Receiving medication known to influence neuromuscular transmission Pregnancy Psychiatric disorders Allergy history to any of the drugs that will be used

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP1- sevoflurane MAC 0.5<br>In this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.5. Propofol infusion is started to keep BIS between 40-60. | Drug: MAC 0.5<br>* 0.5 MAC Sevoflurane<br>Drug: Propofol<br>* Propofol consumption<br>Drug: Rocuronium<br>* Consumption of Rocuronium<br>|
| Experimental: SP2- Sevoflurane MAC 0.75<br>In this group, patient of age 40-60 years, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen.Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.75. Propofol infusion is started to keep BIS between 40-60. | Drug: MAC 0.75<br>* 0.75 MAC Sevoflurane<br>Drug: Propofol<br>* Propofol consumption<br>Drug: Rocuronium<br>* Consumption of Rocuronium<br>|
| Experimental: SP3 -Sevoflurane MAC 1.0<br>In this group, patient of age 40-60 years, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 1.0. Propofol infusion is started to keep BIS between 40-60. | Drug: MAC 1.0<br>* 1.0 MAC Sevoflurane<br>Drug: Propofol<br>* Propofol consumption<br>Drug: Rocuronium<br>* Consumption of Rocuronium<br>|
| Experimental: SP4- Sevoflurane MAC 0.5<br>In this group, patient above 60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Propofol infusion is started to keep BIS between 40-60. | Drug: MAC 0.5<br>* 0.5 MAC Sevoflurane<br>Drug: Propofol<br>* Propofol consumption<br>Drug: Rocuronium<br>* Consumption of Rocuronium<br>|
| Experimental: SP5- Sevoflurane MAC 0.75<br>In this group, patient above 60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.75. Propofol infusion is started to keep BIS between 40-60. | Drug: MAC 0.75<br>* 0.75 MAC Sevoflurane<br>Drug: Propofol<br>* Propofol consumption<br>Drug: Rocuronium<br>* Consumption of Rocuronium<br>|
| Experimental: SE1- Sevoflurane MAC 0.5<br>In this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. | Drug: MAC 0.5<br>* 0.5 MAC Sevoflurane<br>Drug: Etomidate<br>* Etomidate consumption<br>Drug: Rocuronium<br>* Consumption of Rocuronium<br>|
| Experimental: SE2- Sevoflurane 0.75<br>In this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. | Drug: MAC 0.75<br>* 0.75 MAC Sevoflurane<br>Drug: Etomidate<br>* Etomidate consumption<br>Drug: Rocuronium<br>* Consumption of Rocuronium<br>|
| Experimental: SE3- Sevoflurane MAC 1.0<br>In this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. | Drug: MAC 1.0<br>* 1.0 MAC Sevoflurane<br>Drug: Etomidate<br>* Etomidate consumption<br>Drug: Rocuronium<br>* Consumption of Rocuronium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of propofol | Propofol, Etomidate, Rocuronium consumption under specific concentration of sevoflurane keeping BIS between 40-60 | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Index | T25%-T75% | Intraoperative | 
| Onset time | Time from starting infusion of Rocuronium at induction till T<10% | Intraoperative | 
| Sevoflurane time | Time from starting sevoflurane till end tidal concentration is reached | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Sevoflurane, Etomidate, Rocuronium, BIS, Closed loop infusion system