NCT01736371

Brief Summary

The aim in this study was to quantify the difference in cisatracurium and sufentanil consumption, and its recovery period, when patients are under balanced general anesthesia with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed loop computer control infusion. Investigators further investigated this effect on its recovery period and sufentanyl consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

10 months

First QC Date

November 25, 2012

Last Update Submit

November 28, 2012

Conditions

Drug Interaction Potentiation

Keywords

SevofluraneCisatracurium infusion consumptionClosed loop computer control systemRecovery Index

Outcome Measures

Primary Outcomes (1)

  • Cisatracurium consumption rate.

    Measurements were done intraoperatively. Investigators obtained data from the closed loop computer system, from which the intra-operative consumption of cisatracurium were obtained from each patient. Data were collected only during surgery. Each patient had different cisatracurium consumption rate, and the mean consumption rate of the patients within the same group were calculated, and compared with the means from the other groups.

    At the time of surgery.

Secondary Outcomes (1)

  • Analysis of Means of Recovery Index.

    30 minutes post operative.

Other Outcomes (1)

  • Sufentanil Consumption.

    At time of surgery

Study Arms (3)

Total Intravenous Anesthesia

SHAM COMPARATOR

Only propofol infusion is used for maintenance of anesthesia keeping Bispectral Index (BIS) between 45-55.

Drug: Propofol

1% Sevoflurane

ACTIVE COMPARATOR

1% Sevoflurane with propofol infusion is used for maintenance. BIS is kept between 45-55 by adjusting propofol infusion.

Drug: 1% Sevoflurane

Sevoflurane

ACTIVE COMPARATOR

Only Sevoflurane is used for maintenance keeping BIS between 45-55

Drug: Sevoflurane

Interventions

1% SevofluraneDRUG

In this group of patients, the maintenance of anesthesia is done by 1% sevoflurane + propofol infusion. Propofol infusion is adjusted according to the Bispectral Index.

1% Sevoflurane
PropofolDRUG

In this group the maintenance of anesthesia is maintained by only propofol infusion.

Also known as: Total Intravenous Anesthesia
Total Intravenous Anesthesia
SevofluraneDRUG

In this group only sevoflurane was used for maintenance of anesthesia. the dose of sevoflurane is adjusted to maintain Bispectral Index within 45 and 55.

Sevoflurane

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20 and 65.
  • Patients with ASA 1 and 2.
  • Patients for elective abdominal general surgery

You may not qualify if:

  • Patients with the following diseases are excluded, since they are known to cause generalized neuromuscular weakness:
  • Neuromuscular junction disorders (e.g.. myasthenia gravis) Myopathies (e.g.. Muscular Dystrophies, Rhabdomyolysis) Peripheral Neuropathies (e.g. Guillain-Barre Syndrome, Polyneuropathies) Encephalopathies (Septic and Toxic-metabolic Encephalopathy) Patients with renal and liver diseases.
  • Patients who are sent intubated to ICU after surgery.
  • Patients refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University

Tianjin, 300070, China

Location

MeSH Terms

Interventions

SevofluranePropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Shehzaad Joomye, M.D.

    Tianjin Medical University General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Joomye Shehzaad M.D.

Study Record Dates

First Submitted

November 25, 2012

First Posted

November 29, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

CN(1)