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

Deep Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674201
• Other study ID #: SiirtTRH
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Ambulatory Surgery
• Deep Sedation

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