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临床试验/NCT05674201
NCT05674201已完成不适用

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

Siirt Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2
试验地点
1
主要终点
SEDATİON

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AGE 18-65 ASA I AND II

排除标准

  • 未提供

结局指标

主要结局

SEDATİON

时间窗: through study completion, an average of 1 year

RAMSEY SEDATİON SKORE \> 4 TİME (MİNUTE)

END-TİDAL CO2

时间窗: DURING THE SURGERY

END-TİDAL CO2 (mmHg)

DESATURATION DESATURATION

时间窗: DURING THE SURGERY

SATURATION SATURATION RATIOS (%)

RECOVERY

时间窗: through study completion, an average of 1 year

MODIFIED ALDRETE SCORE\>9 (MİNUTE)

RESPİRATORY RATE

时间窗: DURING THE SURGERY

RESPİRATORY RATE (.../MİNUTE)

INTEGRATED PULMONARY INDEX

时间窗: DURING THE SURGERY

INTEGRATED PULMONARY INDEX (1-10)

次要结局

  • NON INVASIVE SYSTOLİC AND BLOOD PRESSURE(DURING THE SURGERY)
  • HEART RATE(DURING THE SURGERY)
  • NON INVASIVE DİASTOLİC BLOOD PRESSURE(DURING THE SURGERY)

研究者

发起方
Siirt Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

ali kendal oğuz

medical doctor

Siirt Training and Research Hospital

研究点 (1)

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