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

Neuromuscular Monitoring Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711917
• Other study ID #: TianjinMUGH
• Secondary ID: Narina Goulvaden
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: March 16, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neuromuscular Monitoring

Intervention

Drug:
• MAC 0.5
0.5 MAC Sevoflurane
• MAC 0.75
0.75 MAC Sevoflurane
• MAC 1.0
1.0 MAC Sevoflurane
• Propofol
Propofol consumption
• Etomidate
Etomidate consumption
• Rocuronium
Consumption of Rocuronium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consumption of propofol	Propofol, Etomidate, Rocuronium consumption under specific concentration of sevoflurane keeping BIS between 40-60	Intraoperative	Yes
Secondary	Recovery Index	T25%-T75%	Intraoperative	Yes
Secondary	Onset time	Time from starting infusion of Rocuronium at induction till T<10%	Intraoperative	Yes
Secondary	Sevoflurane time	Time from starting sevoflurane till end tidal concentration is reached	Intraoperative	Yes