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

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01140100
First received: June 8, 2010
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 .


Condition Intervention Phase
Anesthetics
 Drug: propofol
Drug: thiopental,propofol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Study of Depth of Anesthesia Monitored by BIS Values in Two Anesthesia Techniques

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by Shiraz University of Medical Sciences:

Enrollment: 82
Arms Assigned Interventions
Active Comparator: propofol-propofol Drug: propofol
Experimental: thiopental-propofol Drug: thiopental,propofol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140100

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Principal Investigator: Sina Ghaffaripour, M.D Shiraz University of Medical Sciences
Study Director: Hilda Mahmoudi, M.D Shiraz University of Medical Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01140100     History of Changes
Other Study ID Numbers: 85-3211
Study First Received: June 8, 2010
Last Updated: June 8, 2010
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Anesthetics
Propofol
Thiopental
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants

ClinicalTrials.gov processed this record on May 19, 2013