Evaluation of Different Anesthesia for Uterine Curettage | NCT00733564

Studies
Evaluation of Different Anesthesia for Uterine Curettage

NCT00733564

Sponsor

Nanjing Medical University

Status

Completed

Last Update Posted

Mar 31, 2009Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Uterine Curettage
Abortion, Induced

Interventions

Lidocaine
Propofol
Sevoflurane

Countries

China

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

ID	Type	Description	Link
NJFY0890-MZ12

Status Module

Record Verification Date

Mar 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

Aug 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Aug 11, 2008

First Submission Date that Met QC Criteria

Aug 12, 2008

First Posted Date

Aug 13, 2008Estimated

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

Mar 30, 2009

Last Update Posted Date

Mar 31, 2009Estimated

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

Anesthesia during uterine curettage is a problem. Paracervical block is used in general for such an operation, though, the anesthetic efficacy is incomplete. Propofol is the short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new inhalational anesthetic well-known for it's "easy come, easy go" property. The investigators hypothesized that propofol, sevoflurane and paracervical block had different anesthetic efficacy during uterine curettage. Which one is the optimal selection for such operation needed to be evaluated.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Paracervical block will be performed	Drug: Lidocaine
2	Experimental	Propofol anesthesia will be performed	Drug: Propofol
3	Experimental	Sevoflurane anesthesia will be performed	Drug: Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug	Paracervical injection of 2% Lidocaine to block associated nociception input	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bispectral Index (BIS) value		0, 5, 10, 20, 30min after anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Intraoperative awareness		0, 5, 10, 20, 30min after anesthesia
Vital signs		0, 5, 10, 15, 20, 25, 30min after anesthesia
Arterial blood gas analysis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA status I-II
Performing abortion operation (medical- or surgical)
Requiring painless abortion

Exclusion Criteria:

< 19 yrs, and >=45 yrs
History of central active drugs administration
Drug abuse
Hypertension
Diabetes
Any other chronic diseases
Allergy to the study drugs
Habit of over-volume alcohol drinking
Records of history of centrally active drug use and psychiatry
Any organic disorder

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
XiaoFeng Shen, MD	Nanjing Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Maternal and Child Health Care Hospital		Nanjing	Jiangsu	210004	China

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D015742	Propofol
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided