Clinical trial NCT05674201: Effects Of Propofol-Dexmedetomıdıne And Propofol- Remıfentanıl In Hysteroscopıc Operations.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Sedation
Ambulatory Surgery
Ambulatory Surgical Procedure
Keywords: Ambulatory Anesthesia
Hysteroscopy
Sedation
Dexmedetomidine
Remifentanyl
Lead sponsor: Siirt Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Yuzuncu Yıl University
First posted: 2023-01-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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\&lt;4 were excluded from the study by administering additional propofol.

Eligibility criteria: Inclusion Criteria:

AGE 18-65 ASA I AND II

Exclusion Criteria:

* OTHERS

Primary outcomes:
measure: SEDATİON
timeFrame: through study completion, an average of 1 year
measure: RECOVERY
timeFrame: through study completion, an average of 1 year
measure: DESATURATION DESATURATION
timeFrame: DURING THE SURGERY
measure: RESPİRATORY RATE
timeFrame: DURING THE SURGERY
measure: END-TİDAL CO2
timeFrame: DURING THE SURGERY
measure: INTEGRATED PULMONARY INDEX
timeFrame: DURING THE SURGERY
Secondary outcomes:
measure: HEART RATE
timeFrame: DURING THE SURGERY
measure: NON INVASIVE SYSTOLİC AND BLOOD PRESSURE
timeFrame: DURING THE SURGERY
measure: NON INVASIVE DİASTOLİC BLOOD PRESSURE
timeFrame: DURING THE SURGERY
Other outcomes:
Locations:
city: Siirt
country: Turkey
facility: Siirt Eğitim Ve Araştirma Hastanesi
Study officials:
References: