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

Study Overview
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Brief Summary
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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
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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&lt;4 were excluded from the study by administering additional propofol.

Official Title
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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

Conditions
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Deep Sedation, Ambulatory Surgery, Ambulatory Surgical Procedure

Intervention / Treatment
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* Combination Product: Propofol-Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AGE 18-65 ASA I AND II Exclusion Criteria: OTHERS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group DP<br>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<br>* Propofol-Dexmedetomidine AND Propofol-Remifentanil<br>* Other names: Propofol-Remifentanil;|
| Group RP<br>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<br>* Propofol-Dexmedetomidine AND Propofol-Remifentanil<br>* Other names: Propofol-Remifentanil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambulatory Anesthesia, Hysteroscopy, Sedation, Dexmedetomidine, Remifentanyl