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临床试验/NCT06666686
NCT06666686
已完成
不适用

The Effect of Noise Control During Anesthesia Induction in Laparoscopic Cholecystectomy Surgery on Postoperative Hemodynamic Parameters, Pain, Nausea and Vomiting, and Recovery Time From Anesthesia

Namik Kemal University2 个研究点 分布在 2 个国家目标入组 105 人2024年10月1日

概览

阶段
不适用
干预措施
Control group
疾病 / 适应症
Cholecystectomy, Laparoscopic
发起方
Namik Kemal University
入组人数
105
试验地点
2
主要终点
Patient Identification Form
状态
已完成
最后更新
19天前

概览

简要总结

This study aims to determine the effects of active and passive noise control method and headphone usage and noise level during anesthesia induction in laparoscopic cholecystectomy surgery on hemodynamic parameters, pain, nausea and vomiting, and recovery time from anesthesia in patients after surgery.

详细描述

When the studies in the literature are examined, there is no study evaluating the effects of noise level and active and passive noise control method and headphone usage during anesthesia induction on patients undergoing laparoscopic cholecystectomy surgery, which is the most frequently applied among laparoscopic surgeries. This study aims to eliminate these deficiencies in the literature, to reveal the benefits of active and passive noise control headphone usage for noise control as it is an easy and cheap method and has no side effects, and to popularize this application.

注册库
clinicaltrials.gov
开始日期
2024年10月1日
结束日期
2025年12月31日
最后更新
19天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Namik Kemal University
责任方
Principal Investigator
主要研究者

Cagla AVCU

Research Assistant

Namik Kemal University

入排标准

入选标准

  • Patients aged between 18-65,
  • Diagnosed with cholecystitis or cholelithiasis,
  • Planned for elective laparoscopic cholecystectomy,
  • Have an ASA I or ASA II anesthesia classification,
  • Oriented to person, place and time,
  • Undergoing general anesthesia,
  • Not having a psychiatric or cognitive/mental disease (dementia etc.),
  • Not having vision, hearing and communication problems,
  • Speaking, reading and writing Turkish,
  • Patients who agree to participate in the study verbally and in writing will be included.

排除标准

  • Patients who underwent spinal anesthesia,
  • Transferred to units such as intensive care after surgery,
  • Underwent emergency laparoscopic cholecystectomy,
  • Patients who were planned for elective open cholecystectomy will not be included in the study.

研究组 & 干预措施

Control group

Control group

Active noise control

This is the group where active noise control headphones are applied. Headphones will be applied to patients from the beginning to the end of anesthesia induction.

干预措施: Active noise control headphone

Passive noise control

This is the group where passive noise control headphones are applied. Headphones will be applied to patients from the beginning to the end of anesthesia induction.

干预措施: Passive noise control headphone

结局指标

主要结局

Patient Identification Form

时间窗: Pre-intervention

This form, prepared by researchers in line with the literature, consists of questions about the individual and surgical characteristics of the patients.

Patient Follow-up Form-Part-6

时间窗: in the post-anesthesia care unit (up to 2 hours post surgery)

The part includes the vomiting (if any, how many times), status of premedication, anesthetic drugs, anesthesia induction duration, the duration between anesthesia induction and the termination of anesthesia, and the duration of stay in the post-anesthesia care unit.

Patient Follow-up Form-Part 1

时间窗: perioperative

This part includes the evaluation and recording of the patients' hemodynamic parameters (temperature (°C), pulse rate(dk), respiratory rate (dk), oxygen saturation (%) and blood pressure (mmHg)) after admission to the operating room, during the anesthesia induction phase, during the surgical process from the end of anesthesia induction to the termination of anesthesia and every 15 minutes in the post-anesthesia care unit.

Patient Follow-up Form-Part-2

时间窗: before surgery (anesthesia induction phase)

In this part, the noise level measurement during the anesthesia induction phase will be recorded.

Patient Follow-up Form-Part-3 (Numerical Analog Scale)

时间窗: in the post-anesthesia care unit (up to 2 hours post surgery)

This part is used to measure the pain intensity of patients in the post-anesthesia care unit. The form consists of a 10 cm long ruler with pain intensity scores ranging from 0 to 10, with "0 = No Pain" and "10 = Most Severe Pain".

Patient Follow-up Form-Part-4 (Visual Analog Scale for Assessment of Nausea)

时间窗: in the post-anesthesia care unit (up to 2 hours post surgery)

This scale is used to measure the severity of nausea in patients in the post-anesthesia care unit. The severity of nausea is scored by the patient between 0 and 10 using a 100 mm long ruler, with "0 = No Nausea at All" and "100 = Most Severe Nausea Possible".

Patient Follow-up Form-Part-5 (Modified Aldrete Score)

时间窗: in the post-anesthesia care unit (up to 2 hours post surgery)

It is a scoring system used to assess whether patients are ready to be transferred from the post-anesthesia care unit to the clinic. It consists of 5 parameters: "Activity", "Respiration", "Circulation", "Consciousness" and "Oxygen Saturation" and each parameter is scored as "0", "1" and "2". A total score of 9 and above indicates that transfer to the clinic is appropriate.

Noise Meter

时间窗: before surgery (anesthesia induction phase)

During the anesthesia induction phase, the noise level of the operating room will be measured with a handheld noise measuring device. The device will be placed approximately 120 cm away from the patient's head. The noise level will be measured and recorded from the beginning of anesthesia induction to termination.

研究点 (2)

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