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临床试验/CTRI/2025/09/094500
CTRI/2025/09/094500尚未招募3 期

A comparison between inhalational and total intravenous anaesthesia in providing an early recovery in short gynaecological surgeries: A randomized controlled trial

Amrita Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare the time taken to respond to verbal commands at the end of surgery between 2 groups of patients

研究概览

简要总结

Introduction

The choice of anaesthetic agents and techniques could  influence the occurrence of complications such as postoperative nausea and vomiting (PONV), postoperative behavioural disturbances and cardiorespiratory complications and thus delay discharge. **Dilatation and curettage(**D&C)procedures that involve general anaesthesia are performed with combination of intravenous with  volatile anaesthetics or propofol-based total intravenous anaesthesia. Both these techniques are safe and provide appropriate conditions for surgery. Total inhalation anesthesia is a general anesthetic that uses only inhaled anaesthetics drugs to induce and maintain unconsciousness and is rarely used .Hence it is  unclear whether TIVA or TIA  anaesthesia regimen is better for  short day care procedures like D&C. The present study will be conducted to compare the use of the inhalation anaesthesia technique using sevoflurane and nitrous oxide with the TIVA technique, using propofol and fentanyl.The primary objective of the study will be to compare the incidence and severity of post operative nausea and vomiting between patients receiving inhalational and those receiving total intravenous anaesthesia.

 Methods

After obtaining approval from the hospital Ethics Committee and securing the CTRI clearance, patients will be randomly allocated to either of the two groups [Group P or Group S ] using computer generated random sequence of numbering. Concealment of allocation will be ensured by sequentially numbered opaque sealed envelopes.

Female surgical patients scheduled for D&C procedure will be recruited after a thorough pre-anaesthetic evaluation and consent.

Patients will be fasted 6 hours for solids and 2 hours for clear fluids. No premedication will be given as per the hospital protocol. Pre operatively, on the day of surgery, patients will be explained about the procedure, satisfaction scores and consent will be taken.

In the operation theatre, an intravenous line will be secured and injection glycopyrrolate 0.2mg will be  given to all patients and all pre induction monitors-ECG, NIBP, saturation probe and EtCO2will be attached.

Patients in group P will be induced with iv midazolam 2mg,  fentanyl 1.5mcg/kg, ketamine 0.5mg/kg and titrated doses of propofol till the patient loses consciousness. Additional increments of 10mg propofol will be given when the patient shows signs of inadequate anaesthesia like spontaneous movement, resistance to leg elevation during positioning of the patient or an increase in heart rate or BP and increase in the depth of ventilation. The patients in group S will be induced with 50% nitrous oxide and 5% sevoflurane in oxygen till loss of consciousness and then sevoflurane will be reduced to 2%.

Patients in both groups will be maintained on spontaneous ventilation with a face mask and closed circuit.

All patients will be provided with iv 4mg Ondansetron and 1g paracetamol at the end of surgery. The time to respond to commands after surgery and the surgeon’s satisfaction with anaesthesia provided will be noted in both groups.

PONV, requirement of additional anti-emetic and analgesic, patient satisfaction, time to ambulate and discharge the patient and the cost of anaesthesia will also be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Patients of the American Society of Anaesthesiologists (ASA) physical status 1–2, undergoing dilatation and curettage(D and C) procedures as ambulatory day case procedures under general anaesthesia will be included.

排除标准

  • Patients with known allergy to the drugs used will be excluded from the study.

结局指标

主要结局

To compare the time taken to respond to verbal commands at the end of surgery between 2 groups of patients

时间窗: 4 weeks

次要结局

  • To compare the postoperative nausea and vomiting, surgeon and patient satisfaction(At 1 hr post op)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nitu PV

Amrita Institute of medical Sciences

研究点 (1)

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