Skip to main content
OpenTrials
Completed

NCT Number: NCT05674201

Effects Of Propofol-Dexmedetomıdıne And Propofol- Remıfentanıl In Hysteroscopıc Operations.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Siirt Eğitim Ve Araştirma Hastanesi

Siirt, Turkey (Türkiye)

About this study

This study was conducted prospectively after the approval of Van Yüzüncü Yıl University Ethics Committee. A total of 80 participants in 2 groups of 40 ASA I-II, aged 18-65 years were included in the study. On the day of the operation, vascular access was established with a 20 G branule in all patients before the procedure. The participants who were taken to the gynecology table were routinely monitored in the supine position as required by the procedure.

All participants were premedicated with 0.025 mg/kg Midazolam (Demizolam®, Dem, Turkey) after starting oxygen at 2 lt/min with a nasal cannula. The participants were randomly divided into two groups as Group DP and RP. Propofol (Propofol-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered to both groups. 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. 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.Hemodynamic data and respiratory parameters of the groups before and after sedation were recorded. The depth of anesthesia was recorded using the Ramsey sedation scale, and the recovery scores were recorded with the Modified Aldrete score. The facial pain scale was used to evaluate pain. Depth of anesthesia was provided so that the Ramsey Sedation Scale of the patients was greater than four. Patients with RSS<4 were excluded from the study by administering additional propofol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

AGE 18-65 ASA I AND II

Exclusion criteria

  • OTHERS

Treatment and study plan

Propofol-Dexmedetomidine

Combination Product

Propofol-Dexmedetomidine AND Propofol-Remifentanil

Other names: Propofol-Remifentanil

Primary outcomes

  1. SEDATİON

    Time frame: through study completion, an average of 1 year

    RAMSEY SEDATİON SKORE > 4 TİME (MİNUTE)

  2. RECOVERY

    Time frame: through study completion, an average of 1 year

    MODIFIED ALDRETE SCORE>9 (MİNUTE)

  3. DESATURATION DESATURATION

    Time frame: DURING THE SURGERY

    SATURATION SATURATION RATIOS (%)

  4. RESPİRATORY RATE

    Time frame: DURING THE SURGERY

    RESPİRATORY RATE (.../MİNUTE)

  5. END-TİDAL CO2

    Time frame: DURING THE SURGERY

    END-TİDAL CO2 (mmHg)

  6. INTEGRATED PULMONARY INDEX

    Time frame: DURING THE SURGERY

    INTEGRATED PULMONARY INDEX (1-10)

Secondary outcomes

  1. HEART RATE

    Time frame: DURING THE SURGERY

    HEART RATE (../MİNUTE)

  2. NON INVASIVE SYSTOLİC AND BLOOD PRESSURE

    Time frame: DURING THE SURGERY

    NON INVASIVE BLOOD PRESSURE ( mmHg)

  3. NON INVASIVE DİASTOLİC BLOOD PRESSURE

    Time frame: DURING THE SURGERY

    NON INVASIVE BLOOD PRESSURE ( mmHg)

Sponsors and collaborators

Lead sponsor

Siirt Training and Research Hospital

Other Gov

Collaborators

  • Yuzuncu Yil University

Registry information

Official study title

Effects Of Propofol-Dexmedetomıdıne And Propofol- Remıfentanıl On Recovery And Hemodynamıcs In Hysteroscopıc Operations, That One Of The Ambulatory Anesthesıa Practices: A Randomızed Controlled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 6, 2023
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.