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

Completed
Conditions
Deep Sedation
Ambulatory Surgery
Ambulatory Surgical Procedure
Interventions
Combination Product: Propofol-Dexmedetomidine
Registration Number
NCT05674201
Lead Sponsor
Siirt Training and Research Hospital
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2
Inclusion Criteria

AGE 18-65 ASA I AND II

Exclusion Criteria
  • OTHERS

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Group RPPropofol-DexmedetomidinePropofol (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.
Group DPPropofol-DexmedetomidinePropofol (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.
Primary Outcome Measures
NameTimeMethod
SEDATİONthrough study completion, an average of 1 year

RAMSEY SEDATİON SKORE \> 4 TİME (MİNUTE)

RECOVERYthrough study completion, an average of 1 year

MODIFIED ALDRETE SCORE\>9 (MİNUTE)

END-TİDAL CO2DURING THE SURGERY

END-TİDAL CO2 (mmHg)

DESATURATION DESATURATIONDURING THE SURGERY

SATURATION SATURATION RATIOS (%)

RESPİRATORY RATEDURING THE SURGERY

RESPİRATORY RATE (.../MİNUTE)

INTEGRATED PULMONARY INDEXDURING THE SURGERY

INTEGRATED PULMONARY INDEX (1-10)

Secondary Outcome Measures
NameTimeMethod
NON INVASIVE SYSTOLİC AND BLOOD PRESSUREDURING THE SURGERY

NON INVASIVE BLOOD PRESSURE ( mmHg)

HEART RATEDURING THE SURGERY

HEART RATE (../MİNUTE)

NON INVASIVE DİASTOLİC BLOOD PRESSUREDURING THE SURGERY

NON INVASIVE BLOOD PRESSURE ( mmHg)

Trial Locations

Locations (1)

Siirt Eğitim Ve Araştirma Hastanesi

🇹🇷

Siirt, Turkey

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