A Comparative Study of Depth of Anesthesia Monitored by B... | NCT01140100

Studies
A Comparative Study of Depth of Anesthesia Monitored by Bispectral Index (BIS) Values

NCT01140100

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Jun 9, 2010Estimated

Enrollment

82Actual

Phase

Phase 2

Conditions

Anesthetics

Interventions

propofol
thiopental,propofol

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 8, 2010

First Submission Date that Met QC Criteria

Jun 8, 2010

First Posted Date

Jun 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2010

Last Update Posted Date

Jun 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to determine whether induction of anesthesia with thiopental followed by propofol infusion is able to maintain sufficient depth of anesthesia .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Label	Type	Description	Intervention Names
propofol-propofol	Active Comparator		Drug: propofol
thiopental-propofol	Experimental		Drug: thiopental,propofol

Name	Type	Description	Arm Group Labels	Other Names
propofol	Drug		propofol-propofol
thiopental,propofol

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

being adult
having ASA I or II
scheduled for elective cataract surgery under general anesthesia

Exclusion Criteria:

massive obesity
intake of any central nervous system (CNS) stimulants
intake of CNS depressants
intake of Tricyclic antidepressants
known adverse reaction to the study drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sina Ghaffaripour, M.D	Shiraz University of Medical Sciences	Principal Investigator
Hilda Mahmoudi, M.D	Shiraz University of Medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiraz University of Medical Sciences		Shiraz	Fars		Iran

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D013874	Thiopental

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided