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

March 16, 2016 updated by: Guolin Wang, Tianjin Medical University General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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: Propofol
Propofol consumption
Drug: Rocuronium
Consumption of Rocuronium
Drug: MAC 0.75
0.75 MAC Sevoflurane
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: Propofol
Propofol consumption
Drug: Rocuronium
Consumption of Rocuronium
Drug: MAC 1.0
1.0 MAC Sevoflurane
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: Propofol
Propofol consumption
Drug: Rocuronium
Consumption of Rocuronium
Drug: MAC 0.75
0.75 MAC Sevoflurane
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: Rocuronium
Consumption of Rocuronium
Drug: Etomidate
Etomidate consumption
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: Rocuronium
Consumption of Rocuronium
Drug: MAC 0.75
0.75 MAC Sevoflurane
Drug: Etomidate
Etomidate consumption
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: Rocuronium
Consumption of Rocuronium
Drug: MAC 1.0
1.0 MAC Sevoflurane
Drug: Etomidate
Etomidate consumption

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University General Hospital

Investigators

  • Principal Investigator: Guolin Wang, Professor, Head of department anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TianjinMUGH
  • Narina Goulvaden (Other Identifier: Tianjin medical university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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