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

Sponsor

Tianjin Medical University General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02711917

Collaborator

(none)

175

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Monitoring	Drug: MAC 0.5 Drug: MAC 0.75 Drug: MAC 1.0 Drug: Propofol Drug: Etomidate Drug: Rocuronium	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

175 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SP1- sevoflurane MAC 0.5 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 0.5 MAC Sevoflurane Drug: Propofol Propofol consumption Drug: Rocuronium Consumption of Rocuronium
Experimental: SP2- Sevoflurane MAC 0.75 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 0.75 MAC Sevoflurane Drug: Propofol Propofol consumption Drug: Rocuronium Consumption of Rocuronium
Experimental: SP3 -Sevoflurane MAC 1.0 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 1.0 MAC Sevoflurane Drug: Propofol Propofol consumption Drug: Rocuronium Consumption of Rocuronium
Experimental: SP4- Sevoflurane MAC 0.5 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 0.5 MAC Sevoflurane Drug: Propofol Propofol consumption Drug: Rocuronium Consumption of Rocuronium
Experimental: SP5- Sevoflurane MAC 0.75 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 0.75 MAC Sevoflurane Drug: Propofol Propofol consumption Drug: Rocuronium Consumption of Rocuronium
Experimental: SE1- Sevoflurane MAC 0.5 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 0.5 MAC Sevoflurane Drug: Etomidate Etomidate consumption Drug: Rocuronium Consumption of Rocuronium
Experimental: SE2- Sevoflurane 0.75 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 0.75 MAC Sevoflurane Drug: Etomidate Etomidate consumption Drug: Rocuronium Consumption of Rocuronium
Experimental: SE3- Sevoflurane MAC 1.0 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 1.0 MAC Sevoflurane Drug: Etomidate Etomidate consumption Drug: Rocuronium Consumption of Rocuronium

Outcome Measures

Primary Outcome Measures

consumption of propofol [Intraoperative]
Propofol, Etomidate, Rocuronium consumption under specific concentration of sevoflurane keeping BIS between 40-60

Secondary Outcome Measures

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