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Comparing Two Types of Sedation to Gynaecological Patients

Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01412632
Enrollment
153
Registered
2011-08-09
Start date
2011-11-30
Completion date
2013-08-31
Last updated
2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcervical Resection of Endometrium, Transcervical Resection of Fibroids, Transcervical Resection of Polyp

Brief summary

The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.

Detailed description

Investigate the difference between two types of anesthesia.

Interventions

DRUGRemifentanil, propofol and citanest

iv remifentanil iv propofol im citanest

Sponsors

Regionshospitalet Horsens
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* \>18 years * females * are having a TCRE, TCRF or TCRP * speak and understand Danish * no mental problems

Exclusion criteria

* \<18 years old * don´t speak or understand Danish * mental problems * Lung problems * BMI \>40 * Big fibroma: \>3x3 cm * abuser * Allergy towards i Propofol, Remifentanil and/or Citanest * pregnant

Design outcomes

Primary

MeasureTime frameDescription
pain on a NRS-scale from 0 to 10up to 14 daysMeasuring postoperative pain in TCRE, TCRF or TCRP patients

Secondary

MeasureTime frameDescription
PONVpostoperative and 2 weeks after discharge
Time1 dayOperating time Recovery time Discharge time
Medicin1 dayThe type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.
After discharge outcome measures2 weeksPrevious anestetics, pain, PONV, fever, bleeding, discharge time.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026