NCT05674201

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Siirt Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Sedation
• Ambulatory Surgery
• Ambulatory Surgical Procedure

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Propofol-Dexmedetomidine	Propofol-Dexmedetomidine AND Propofol-Remifentanil

Timeline

• Start date: 2021-06-17
• Primary completion: 2021-08-01
• Completion: 2022-07-15
• First posted: 2023-01-06
• Last updated: 2023-01-06

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study