NCT02711917

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

February 24, 2016

Last Update Submit

March 16, 2016

Conditions

Keywords

PropofolSevofluraneEtomidateRocuroniumBISClosed loop infusion system

Outcome Measures

Primary Outcomes (1)

  • consumption of propofol

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

    Intraoperative

Secondary Outcomes (3)

  • Recovery Index

    Intraoperative

  • Onset time

    Intraoperative

  • Sevoflurane time

    Intraoperative

Study Arms (8)

SP1- sevoflurane MAC 0.5

EXPERIMENTAL

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 0.5Drug: PropofolDrug: Rocuronium

SP2- Sevoflurane MAC 0.75

EXPERIMENTAL

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 0.75Drug: PropofolDrug: Rocuronium

SP3 -Sevoflurane MAC 1.0

EXPERIMENTAL

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 1.0Drug: PropofolDrug: Rocuronium

SP4- Sevoflurane MAC 0.5

EXPERIMENTAL

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 0.5Drug: PropofolDrug: Rocuronium

SP5- Sevoflurane MAC 0.75

EXPERIMENTAL

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 0.75Drug: PropofolDrug: Rocuronium

SE1- Sevoflurane MAC 0.5

EXPERIMENTAL

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 0.5Drug: EtomidateDrug: Rocuronium

SE2- Sevoflurane 0.75

EXPERIMENTAL

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 0.75Drug: EtomidateDrug: Rocuronium

SE3- Sevoflurane MAC 1.0

EXPERIMENTAL

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 1.0Drug: EtomidateDrug: Rocuronium

Interventions

0.5 MAC Sevoflurane

SE1- Sevoflurane MAC 0.5SP1- sevoflurane MAC 0.5SP4- Sevoflurane MAC 0.5

0.75 MAC Sevoflurane

SE2- Sevoflurane 0.75SP2- Sevoflurane MAC 0.75SP5- Sevoflurane MAC 0.75

1.0 MAC Sevoflurane

SE3- Sevoflurane MAC 1.0SP3 -Sevoflurane MAC 1.0

Propofol consumption

SP1- sevoflurane MAC 0.5SP2- Sevoflurane MAC 0.75SP3 -Sevoflurane MAC 1.0SP4- Sevoflurane MAC 0.5SP5- Sevoflurane MAC 0.75

Etomidate consumption

SE1- Sevoflurane MAC 0.5SE2- Sevoflurane 0.75SE3- Sevoflurane MAC 1.0

Consumption of Rocuronium

SE1- Sevoflurane MAC 0.5SE2- Sevoflurane 0.75SE3- Sevoflurane MAC 1.0SP1- sevoflurane MAC 0.5SP2- Sevoflurane MAC 0.75SP3 -Sevoflurane MAC 1.0SP4- Sevoflurane MAC 0.5SP5- Sevoflurane MAC 0.75

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \< 30
  • elective Gynaecological/abdominal/urological surgery
  • Operation time \< 3hrs
  • ASA I/II
  • Intubated patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PropofolEtomidateRocuronium

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Guolin Wang, Professor

    Head of department anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 17, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

March 17, 2016

Record last verified: 2016-03