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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05674201
Other study ID # SiirtTRH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 17, 2021
Est. completion date July 15, 2022

Study information

Verified date December 2022
Source Siirt Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date July 15, 2022
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: AGE 18-65 ASA I AND II Exclusion Criteria: - OTHERS

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Propofol-Dexmedetomidine
Propofol-Dexmedetomidine AND Propofol-Remifentanil

Locations

Country Name City State
Turkey Siirt Egitim Ve Arastirma Hastanesi Siirt

Sponsors (2)

Lead Sponsor Collaborator
Siirt Training and Research Hospital Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary SEDATION RAMSEY SEDATION SKORE > 4 TIME (MINUTE) through study completion, an average of 1 year
Primary RECOVERY MODIFIED ALDRETE SCORE>9 (MINUTE) through study completion, an average of 1 year
Primary DESATURATION DESATURATION SATURATION SATURATION RATIOS (%) DURING THE SURGERY
Primary RESPIRATORY RATE RESPIRATORY RATE (.../MINUTE) DURING THE SURGERY
Primary END-TIDAL CO2 END-TIDAL CO2 (mmHg) DURING THE SURGERY
Primary INTEGRATED PULMONARY INDEX INTEGRATED PULMONARY INDEX (1-10) DURING THE SURGERY
Secondary HEART RATE HEART RATE (../MINUTE) DURING THE SURGERY
Secondary NON INVASIVE SYSTOLIC AND BLOOD PRESSURE NON INVASIVE BLOOD PRESSURE ( mmHg) DURING THE SURGERY
Secondary NON INVASIVE DIASTOLIC BLOOD PRESSURE NON INVASIVE BLOOD PRESSURE ( mmHg) DURING THE SURGERY
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