Effect of Cisatracurium Versus Atracurium on Intraocular... | NCT01273831

Studies
Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia

NCT01273831

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Jan 11, 2011Estimated

Enrollment

90Actual

Phase

Phase 2

Conditions

Intraocular Pressure

Interventions

atracurium
cisatracurium

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

Jul 2009

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

Jul 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jan 10, 2011

First Submission Date that Met QC Criteria

Jan 10, 2011

First Posted Date

Jan 11, 2011Estimated

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

Jan 10, 2011

Last Update Posted Date

Jan 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to determine which drug makes lower intraocular pressure

Detailed Description

Increase in intraocular pressure (IOP) following tracheal intubation during general anesthesia can be troublesome. The investigators compared the influence of cisatracurium and atracurium on IOP in patients undergoing general anesthesia.

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
atracurium	Other	Patients who underwent general anesthesia received atracurium	Drug: atracurium
cisatracurium	Other	Patients who underwent general anesthesia received cisatracurium	Drug: cisatracurium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
atracurium	Drug	atracurium, Drop,0.5 mg/kg, one time, one day	atracurium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraocular pressure	determining intraocular pressure in atracurium and cisatracurium groups	at 2 minutes after intubation

Secondary Outcomes

Measure	Description	Time Frame
systolic blood pressure	identification of systolic blood pressure in atracurium and cisatracurium groups	at 2 minutes after intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA class of I or II baseline IOP of lower than 20 mmHg stable hemodynamics no history of ophthalmic diseases not using drugs affecting IOP (e.g. anticholinergics, sympathomimetics) no contraindication for atracurium or cisatracurium administration.

Exclusion Criteria:

difficulty in mask ventilation or in tracheal intubation end expiratory CO2 of below 35 mmHg or over 45 mmHg O2 saturation of below 90%

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mitra Jabalameri, A.Professor	Associate Professor,Anesthesiology department	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-zahra university hospital		Isfahan	Isfahan		Iran

Intervention Browse Module

MeSH Terms

ID	Term
D001279	Atracurium
C101584	cisatracurium

Ancestor Terms

ID	Term
D044182	Benzylisoquinolines
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided