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

NCT ID: NCT05674201

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-17

Study Completion Date

2022-07-15

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\<4 were excluded from the study by administering additional propofol.

Conditions

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Deep Sedation Ambulatory Surgery Ambulatory Surgical Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group DP

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.

Propofol-Dexmedetomidine

Intervention Type COMBINATION_PRODUCT

Propofol-Dexmedetomidine AND Propofol-Remifentanil

Group RP

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.

Propofol-Dexmedetomidine

Intervention Type COMBINATION_PRODUCT

Propofol-Dexmedetomidine AND Propofol-Remifentanil

Interventions

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Propofol-Dexmedetomidine

Propofol-Dexmedetomidine AND Propofol-Remifentanil

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Propofol-Remifentanil

Eligibility Criteria

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Inclusion Criteria

AGE 18-65 ASA I AND II

Exclusion Criteria

* OTHERS
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role collaborator

Siirt Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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ali kendal oğuz

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Siirt Eğitim Ve Araştirma Hastanesi

Siirt, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Oguz AK, Soyalp C, Tuncdemir YE, Tekeli AE, Yuzkat N. Sedoanalgesia with dexmedetomidine in daily anesthesia practices: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jan 29;25(1):45. doi: 10.1186/s12871-025-02918-1.

Reference Type DERIVED
PMID: 39881245 (View on PubMed)

Other Identifiers

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SiirtTRH

Identifier Type: -

Identifier Source: org_study_id

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