NCT05674201

Brief Summary

In our study, the investigators aimed to compare the effects of dexmedetomidine-propofol and remifentanil-propofol combinations on perioperative spontaneous respiration, hemodynamics, recovery, participants, surgeon and anesthetist satisfaction in hysteroscopy, which is one of the ambulatory surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
Last Updated

January 6, 2023

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

December 7, 2022

Last Update Submit

December 29, 2022

Conditions

Keywords

Ambulatory AnesthesiaHysteroscopySedationDexmedetomidineRemifentanyl

Outcome Measures

Primary Outcomes (6)

  • SEDATİON

    RAMSEY SEDATİON SKORE \> 4 TİME (MİNUTE)

    through study completion, an average of 1 year

  • RECOVERY

    MODIFIED ALDRETE SCORE\>9 (MİNUTE)

    through study completion, an average of 1 year

  • DESATURATION DESATURATION

    SATURATION SATURATION RATIOS (%)

    DURING THE SURGERY

  • RESPİRATORY RATE

    RESPİRATORY RATE (.../MİNUTE)

    DURING THE SURGERY

  • END-TİDAL CO2

    END-TİDAL CO2 (mmHg)

    DURING THE SURGERY

  • INTEGRATED PULMONARY INDEX

    INTEGRATED PULMONARY INDEX (1-10)

    DURING THE SURGERY

Secondary Outcomes (3)

  • HEART RATE

    DURING THE SURGERY

  • NON INVASIVE SYSTOLİC AND BLOOD PRESSURE

    DURING THE SURGERY

  • NON INVASIVE DİASTOLİC BLOOD PRESSURE

    DURING THE SURGERY

Study Arms (2)

Group DP

Propofol (Dexmedetomidine (Sedadomide 200 µg/2 ml, KOÇAK FARMA Turkey) 1mcg/kg bolus was administered to Group DP in 10 minutes, then 0.2-1.4 mcg/kg/hour infusion dose was started.-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered.

Combination Product: Propofol-Dexmedetomidine

Group RP

Propofol (Propofol-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered, After a 0.25mcg/kg bolus of Remifentanil (Ultiva®, GlaxoSmithKline, Belgium) was administered to Group RP, a 0.025-0.1mcg/kg/minute infusion dose was started.

Combination Product: Propofol-Dexmedetomidine

Interventions

Propofol-DexmedetomidineCOMBINATION_PRODUCT

Propofol-Dexmedetomidine AND Propofol-Remifentanil

Also known as: Propofol-Remifentanil
Group DPGroup RP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study was conducted prospectively after the approval of Van Yüzüncü Yıl University Ethics Committee. A total of 80 patients in 2 groups of 40 ASA I-II, aged 18-65 years were included in the study.

You may qualify if:

  • AGE 18-65 ASA I AND II

You may not qualify if:

  • OTHERS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt Eğitim Ve Araştirma Hastanesi

Siirt, Turkey (Türkiye)

Location

Related Publications (1)

  • Oguz AK, Soyalp C, Tuncdemir YE, Tekeli AE, Yuzkat N. Sedoanalgesia with dexmedetomidine in daily anesthesia practices: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jan 29;25(1):45. doi: 10.1186/s12871-025-02918-1.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

December 7, 2022

First Posted

January 6, 2023

Study Start

June 17, 2021

Primary Completion

August 1, 2021

Study Completion

July 15, 2022

Last Updated

January 6, 2023

Record last verified: 2022-12

Locations