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

C

Copenhagen University Hospital at Herlev

Status

Unknown

Conditions

Ambulatory Surgery
Conscious Sedation
Anesthesia Recovery Period
Remifentanil
Hysteroscopic Surgery

Treatments

Other: local anaesthesia and remifentanil sedation
Other: total intravenous anaesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT00763789
H-D-2008-031

Details and patient eligibility

About

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.

Enrollment

96 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

1
Experimental group
Description:
Local anaesthesia and remifentanil sedation
Treatment:
Other: local anaesthesia and remifentanil sedation
2
Other group
Description:
Total intravenous anaesthesia
Treatment:
Other: total intravenous anaesthesia

Trial contacts and locations

1

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Central trial contact

Birgitte Majholm, MD; Jørgen H Andersen, M.sc

Data sourced from clinicaltrials.gov

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