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

December 29, 2022 updated by: ali kendal oğuz, Siirt Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Siirt, Turkey
        • Siirt Eğitim Ve Araştirma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

AGE 18-65 ASA I AND II

Exclusion Criteria:

  • OTHERS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Propofol-Dexmedetomidine AND Propofol-Remifentanil
Other Names:
  • Propofol-Remifentanil
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
Propofol-Dexmedetomidine AND Propofol-Remifentanil
Other Names:
  • Propofol-Remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SEDATİON
Time Frame: through study completion, an average of 1 year
RAMSEY SEDATİON SKORE > 4 TİME (MİNUTE)
through study completion, an average of 1 year
RECOVERY
Time Frame: through study completion, an average of 1 year
MODIFIED ALDRETE SCORE>9 (MİNUTE)
through study completion, an average of 1 year
DESATURATION DESATURATION
Time Frame: DURING THE SURGERY
SATURATION SATURATION RATIOS (%)
DURING THE SURGERY
RESPİRATORY RATE
Time Frame: DURING THE SURGERY
RESPİRATORY RATE (.../MİNUTE)
DURING THE SURGERY
END-TİDAL CO2
Time Frame: DURING THE SURGERY
END-TİDAL CO2 (mmHg)
DURING THE SURGERY
INTEGRATED PULMONARY INDEX
Time Frame: DURING THE SURGERY
INTEGRATED PULMONARY INDEX (1-10)
DURING THE SURGERY

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HEART RATE
Time Frame: DURING THE SURGERY
HEART RATE (../MİNUTE)
DURING THE SURGERY
NON INVASIVE SYSTOLİC AND BLOOD PRESSURE
Time Frame: DURING THE SURGERY
NON INVASIVE BLOOD PRESSURE ( mmHg)
DURING THE SURGERY
NON INVASIVE DİASTOLİC BLOOD PRESSURE
Time Frame: DURING THE SURGERY
NON INVASIVE BLOOD PRESSURE ( mmHg)
DURING THE SURGERY

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siirt Training and Research Hospital

Collaborators

Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 29, 2022

First Posted (Estimate)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

December 29, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SiirtTRH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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