Local Anaesthesia and Remifentanil Sedation Versus Total... | NCT00763789

Studies
Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.

NCT00763789

Sponsor

Copenhagen University Hospital at Herlev

Status

Unknown status

Last Update Posted

Jan 6, 2010Estimated

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Conscious Sedation
Remifentanil
Hysteroscopic Surgery
Anesthesia Recovery Period
Ambulatory Surgery

Interventions

local anaesthesia and remifentanil sedation
total intravenous anaesthesia

Countries

Denmark

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

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Not provided

Completion Date

Sep 2010Estimated

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 1, 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

Jan 5, 2010

Last Update Posted Date

Jan 6, 2010Estimated

Description Module

Brief Summary

The purpose of this study is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in the operation room, the time to full mobilisation postoperatively and the time to complete recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.

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

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Local anaesthesia and remifentanil sedation	Other: local anaesthesia and remifentanil sedation
2	Other	Total intravenous anaesthesia	Other: total intravenous anaesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
local anaesthesia and remifentanil sedation	Other		1
total intravenous anaesthesia

Measure	Description	Time Frame
the total time spent in the operating room

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years,
ASA classification I-II
Speaks and writes danish
Signed informed consent

Exclusion Criteria:

ASA classification III-VI
Emotional disorder - medically treated within a week before surgery
Patients in risk of perioperative aspiration - who must be intubated
BMI > 35
Patients who have been using pain medicine within a week before surgery (except PCM and NSAID)
Patients who have been using sleeping medicine or sedatives within a week before surgery

Accepts Healthy Volunteers

Sex

Female

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

Name	Role	Phone	Extension	Email
Birgitte Majholm, MD	Contact	+4544883595		Birmaj01@heh.regionh.dk
Jørgen H Andersen, M.sc	Contact	+4544884782		johvan01@heh.regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital Herlev	Recruiting	Copenhagen		DK-2730	Denmark

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia