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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05674201
Enrollment
2
Registered
2023-01-06
Start date
2021-06-17
Completion date
2022-07-15
Last updated
2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Surgery, Ambulatory Surgical Procedure, Deep Sedation

Keywords

Ambulatory Anesthesia, Hysteroscopy, Sedation, Dexmedetomidine, Remifentanyl

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.

Interventions

COMBINATION_PRODUCTPropofol-Dexmedetomidine

Propofol-Dexmedetomidine AND Propofol-Remifentanil

Sponsors

Yuzuncu Yil University
CollaboratorOTHER
Siirt Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

AGE 18-65 ASA I AND II

Exclusion criteria

* OTHERS

Design outcomes

Primary

MeasureTime frameDescription
INTEGRATED PULMONARY INDEXDURING THE SURGERYINTEGRATED PULMONARY INDEX (1-10)
DESATURATION DESATURATIONDURING THE SURGERYSATURATION SATURATION RATIOS (%)
RESPİRATORY RATEDURING THE SURGERYRESPİRATORY RATE (.../MİNUTE)
END-TİDAL CO2DURING THE SURGERYEND-TİDAL CO2 (mmHg)
SEDATİONthrough study completion, an average of 1 yearRAMSEY SEDATİON SKORE \> 4 TİME (MİNUTE)
RECOVERYthrough study completion, an average of 1 yearMODIFIED ALDRETE SCORE\>9 (MİNUTE)

Secondary

MeasureTime frameDescription
NON INVASIVE SYSTOLİC AND BLOOD PRESSUREDURING THE SURGERYNON INVASIVE BLOOD PRESSURE ( mmHg)
NON INVASIVE DİASTOLİC BLOOD PRESSUREDURING THE SURGERYNON INVASIVE BLOOD PRESSURE ( mmHg)
HEART RATEDURING THE SURGERYHEART RATE (../MİNUTE)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026