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临床试验/NCT06412861
NCT06412861已完成不适用

Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Surgical satisfaction

研究概览

简要总结

Comparison of fentanyl-propofol and ketamine-propofol combination for sedation in brief gynecological cases

Our study aimed to evaluate ketamine-propofol and fentanyl-propofol combinations in short-term gynecological cases in terms of hemodynamic parameters, recovery, complications, patient and physician comfort.

详细描述

Procedural sedation is widely used in various medical procedures worldwide, aiming to suppress consciousness adequately and provide sufficient analgesia while preserving the patient's cardiorespiratory function during painful or unpleasant interventions (1,2). Many drugs are used alone or in combination for this purpose (e.g., benzodiazepines, opioids such as fentanyl and remifentanil, midazolam, ketamine, propofol, dexmedetomidine) (6). This prospective, randomized, double-blind study will evaluate the effectiveness of ketamine-propofol and fentanyl-propofol combinations during short-term gynecological procedures by comparing the frequency of lower extremity movements in sedated patients.

Participants eligible for the study will include individuals aged 18-65 with American Society of Anesthesiologists (ASA) physical status I or II undergoing short gynecological procedures lasting less than 30 minutes. Participants with allergies to study medications, obesity, or behavioral disorders will be excluded. All participants will provide written informed consent the day before the procedure.

Enrolled participants will be divided into two groups: Group K, receiving ketamine and propofol, and Group F, receiving fentanyl and propofol. Heart rate (HR), arterial blood pressure (ABP), peripheral oxygen saturation (SpO2), Ramsey Sedation Score( 1: Awake; agitated or restless or both, 2: Awake; cooperative, oriented, and tranquil,3: Awake but responds to commands only, 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus,5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus, 6: Asleep; no response to glabellar tap or loud auditory stimulus)( RSS), and Facial Pain Score(0:No hurt- 10:Hurts worst (FPS) will be evaluated at five time points: T1 (pre-induction), T2 (1 minute post-induction), T3 (3 minutes post-induction), T4 (end of surgery), and T5 (30 minutes postoperatively).

) In Group K, ketamine-propofol will be prepared in a 1:1 ratio (both 10 mg/mL) in the same syringe, while in Group F, fentanyl (1-2 mcg/kg) and propofol (1 mg/kg) will be prepared separately. Sedation will be initiated with 0.2 mL/kg of ketofol. Surgery will commence if RSS > 4; if the desired sedation level is not achieved, a rescue dose of 0.5 mg/kg propofol bolus will be administered.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients between the ages of 18-65,
  • American Society of Anesthesiologists (ASA) I-II,

排除标准

  • Patients with a known allergy to any of the drugs used in the study,
  • Renal, hepatic, neuro-psychiatric, cardiovascular, or respiratory diseases, i
  • intracranial space-occupying lesions,
  • Pregnant women,
  • Body mass index (BMI) > 30

研究组 & 干预措施

ketamine-propofol

Active Comparator

0.5 mg/kg ketamine + 1 mg/kg propofol will be administered. Ramsey Sedation Score will be targeted to be > 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

干预措施: Ketamine (Drug)

fentanyl-propofol

Active Comparator

1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be > 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

干预措施: Fentanyl (Drug)

结局指标

主要结局

Surgical satisfaction

时间窗: Postoperative procedure

Surgical satisfaction survey: Was the level of sedation sufficient during local anesthesia administration? Was the level of sedation sufficient throughout the surgical procedure? Was your verbal communication level with the patient sufficient? Would you recommend this sedation method to other surgeons for this surgical procedure? Would you accept using the same sedation technique for your next surgical procedure with the patient? Scoring: Ratings are based on a scale of 0 to 2, where 0 indicates 'not at all', 1 indicates 'somewhat', and 2 indicates 'completely'. The scores are evaluated on a scale from the lowest '0' to the highest '10'."

Incidence of lower extremity movement during the procedure

时间窗: intraoperative

The incidence of lower extremity movement indicative of inadequate sedation or analgesia during the procedure

次要结局

  • Adverse events (such as nausea, vomiting, airway obstruction, apnea, desaturation, respiratory depression, hypotension and bradycardia)(30th minute postoperative)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilke Tamdogan

Principal Investigator

Ondokuz Mayıs University

研究点 (1)

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