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临床试验/CTRI/2024/10/074990
CTRI/2024/10/074990招募中不适用

Fast track anaesthesia with desflurane in adult patients undergoing gastrointestinal (laparoscopic) surgeries – A study of 50 cases.

Sumandeep Vidyapeeth1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月21日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
To monitor mean time for extubation after stopping inhalational agent

研究概览

简要总结

Background: Laparoscopic surgeries patients receiving general anesthesia are usually transferred from the operating room (OR) to the post anesthesia care unit (PACU) and then to the ward. However they required to meet PACU discharge criteria for that. The availability of rapid and shorter-acting intravenous (i.v.) (e.g., propofol) and volatile (e.g., desflurance).

AIM

To observe emergence from desflurane anesthesia and thereby facilitate fast-track of post surgical patients (from operating room to recovery unit/ward) undergoing gastrointestinal (Laparoscopic) surgeries.

OBJECTIVES

1.     To monitor flow of oxygen and nitrous oxide, oxygen saturation, peri-operative haemodynamic parameters, end tidal concentration of desflurane and end tidal CO2 intra-operatively.

2.     To monitor mean time for extubation after stopping inhalational agent

3.     Time of shifting from operating room to recovery unit by White’s fast track score system.

4.     Side effects or complications if any.

INCLUSION CRITERIA:

1.     Patients willing to sign the written informed consent.

2.     ASA Grade I-III.

3.     Age between 18-65 years.

4.     Planned for elective gastrointestinal (Laparoscopic) surgeries (eg. Lap. Cholecystectomy, lap. Appendicectomy, lap. Hernioplasty etc.).

EXCLUSION CRITERIA:

1.     Patients with history of prior sore throat, patients with known upper respiratory tract infection or lower respiratory tract infection.

2.     Patients with a history of allergy to anesthetic drugs, including volatile anesthetics.

3.     Potentially susceptible to malignant hyperthermia (personal or family history).

4.     With history of known chronic alcohol or narcotic substance abuse within 90 days of surgery.

5.     With a disabling disease of the central nervous system.

6.     With severe obstructive or restrictive pulmonary disease.

Methodology:

Patients will be given general anaesthesia. Anaesthesia will be maintained with age-adjusted 1 minimum alveolar concentration (MAC) target concentrations of desflurane along with oxygen (50%) and nitrous oxide (50%) and Inj. atracurium as muscle relaxant under peripheral nerve stimulator (PNS) guidance. Minimum fresh gas flow (FGF) will be 1L min-1, administered via a circle breathing system with a carbon dioxide absorber with the use of gas monitor.

Hemodynamics will be recorded immediately after tracheal intubation, at skin incision and at 1 minute after skin incision, then after every 10 minutes till the extubation. Post extubation White’s fast track scoring will be done at 1 minute interval till the score will be ≥ 12. Intra-operative hemodynamic stability will be ensured by adequate volume replacement, continuous urine output monitoring, and/or vasoactive drugs as needed.

ETHICAL ISSUES

·      Permission will be taken from the ethical committee before conducting the study.

·      Written and informed consent from all patients before study.

·      It’s a prospective observational study.

·      This is university funded high intensity research project, so patients are not expected to bear any extra cost for the purpose of study.

·      Any change in the methodology will be informed to the ethical committee.

LIKELY OUTCOME /BENEFITS OF STUDY

·      We will get to know efficacy of desflurane along with end tidal gas analyzer for better emergence of the patient and fast tracking of patients from operation room to bypassing PACU / recovery unit.

·      Early ambulation of the patient.

·      Less stay in hospital and bed occupancy thus reducing economical burden.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to sign the written informed consent.
  • ASA Grade I-III.
  • Age between 18-65 years.
  • Planned for elective gastrointestinal (Laparoscopic) surgeries (eg.
  • Cholecystectomy, lap.
  • Appendicectomy, lap.
  • Hernioplasty etc.).

排除标准

  • Patients with history of prior sore throat, patients with known upper respiratory tract infection or lower respiratory tract infection.
  • Patients with a history of allergy to anesthetic drugs, including volatile anesthetics.
  • Potentially susceptible to malignant hyperthermia (personal or family history).
  • With history of known chronic alcohol or narcotic substance abuse within 90 days of surgery.
  • With a disabling disease of the central nervous system.
  • With severe obstructive or restrictive pulmonary disease.

结局指标

主要结局

To monitor mean time for extubation after stopping inhalational agent

时间窗: Post extubation White’s fast track scoring will be done at 1 minute interval till the score will be ≥ 12

次要结局

  • To monitor flow of oxygen & nitrous oxide, oxygen saturation, peri-operative haemodynamic parameters, end tidal of desflurane & end tidal CO2 intra-operatively.(Time of shifting from operating room to recovery unit by White’s fast track score system)

研究者

发起方
Sumandeep Vidyapeeth
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Tejash H Sharma

Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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