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临床试验/CTRI/2024/11/076927
CTRI/2024/11/076927已完成4 期

Comparison of the Effectiveness of Regional versus General Anaesthesia for Laparoscopic Gynecological and Surgical Procedures

Rajiv Gandhi institute of Medical Sciences Adilabad Telangana1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月30日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Better pain scores stable hemodynamic parameters comfort level and sedation scores with regional anaesthesia

研究概览

简要总结

AIM and OBJECTIVES

The aim of this study is to evaluate the efficacy of regional anesthesia in patients undergoing laparoscopic gynecological surgical procedures in terms of patient comfort, haemodynamic parameters, sedation scores, duration of analgesia and surgeon comfort levels.

REVIEW OF LITERATURE

General anesthesia (GA) is the most common and used technique for laparoscopic surgeries, because it controls surgical pain and improves patient comfort [1]; however, it is responsible for different adverse effects in the postoperative period including the need for rescue analgesics and antiemetics [2, 3]. The surgery, performed under regional anesthesia (RA), allows patient being admitted and discharged on the same day or within 24 h, lowering the risk of nosocomial infection, providing cost-effectiveness and earlier mobilization [4, 5].

It is responsible for less surgical stress response, postoperative pain, lower incidence of postoperative nausea and vomiting, and rapid bowel canalization [10]. Till before the Covid pandemic, only few cases on total laparoscopic hysterectomy are described in the literature [1]. But during the pandemic the need to minimise the spread of Covid infection and to follow safety protocols led anesthesiologists to explore the various methods of regional anesthesia.

MATERIALS AND METHODOLOGY

This is a Prospective Randomised single-blinded controlled study to be conducted at a tertiary care hospital RAJIV GANDHI INSTITUTE OF MEDICAL SCIENCES, ADILABAD, TELANGANA, India.

The patients will be randomly allocated to receive either General or regional anesthesia for the surgery. Baseline hemodynamic parameters will be monitored and appropriate anesthesia administered as per the protocol. If any discomfort for the patient or operating field discomfort to the surgeon, appropriate measures will be taken like sedation, pain relief medications or conversion to general anesthesia.

The following data will be analysed to determine the efficacy of the mode of anesthesia

  • Mode of anesthesia administered: General, Regional or combination

  • Pain scores,comfort levels and sedation scores at various intervals

  • Hemodynamic parameters during the surgery

  • Comfort score of the operating surgeon based on field visibility, additional ports access

  • Time of mobilization in the post operative period and day of discharge

STATISTICAL ANALYSIS

  1. Statistical analysis will done using the SPSS software.

  2. Student`s t-test will be used for analyzing age, weight, MAP, HR, RR, duration of surgery and onset times

  3. Repeated measures analysis of variance is used to compare continuous variables. The difference in continuous parameters such as patient characteristics, preoperative data and amount of supplemental analgesic will be analyzed using one-way analysis of variance.

  4. Chi-Square test is used to analyze ASA class and modes of anesthesia, drug requirements between the two groups.

  5. Kruskal Wallis test will be used for non-parametric quantitative data like VAS score for post operative pain intensity and Ramsey’s sedation scores.

  6. A p-value of less than 0.05 is considered statistically significant

REFERENCES

  1. Munro A, Sjaus A, George RB (2018) Anesthesia and analgesia for gynecological surgery. Curr Opin Anaesthesiol 31(3):274–279.

  2. Stones J, Yates D (2019) Clinical risk assessment tools in anaesthesia. BJA Educ 19(2):47–53.

  3. Harris M, Chung F (2013) Complications of general anesthesia. Clin Plast Surg 40(4):503–513

  4. Darwin L (2016) Patient selection for day surgery. Anaesthesia & Intensive Care Medicine 17(3):151–154

  5. Ljungqvist O, Scott M, Fearon KC (2017) Enhanced recovery after surgery: a review. JAMA Surg 152(3):292–298

  6. Luigi Della ,Corte Antonio Mercorio, Mario Palumbo, Francesco Viciglione, Valeria Cafasso Minimally invasive anesthesia for laparoscopic hysterectomy: a case series, Archives of Gynecology and Obstetrics (2022) 306:2001–2007

  7. Major, A.L.; Jumaniyazov, K.; Yusupova, S.; Jabbarov, R.; Saidmamatov, O.; Mayboroda-Major, I. Laparoscopy in Gynecologic and Abdominal Surgery in Regional (Spinal, Peridural) Anesthesia, the Utility of the Technique during COVID-19 Pandemic. Medicines 2021, 8, 60

  8. Col R.K. Singh, Lt Col A.M. Saini, Lt Col Nitin Goel, Col Dinesh Bisht, Col Atul Seth, Major laparoscopic surgery under regional anesthesia: A prospective feasibility study, Medical journal armed forces India 71(2015)126-131

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
19.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All patients of ASA grade I and II, undergoing laparoscopic surgical and gynaecological surgeries.

排除标准

  • Patients with the following conditions will be excluded cardiac diseases IHD CAD respiratory diseases COPD ILD Asthma neuropsychiatric disorders Obese patients Obstructive sleep apnea Difficult airway and intubation.

结局指标

主要结局

Better pain scores stable hemodynamic parameters comfort level and sedation scores with regional anaesthesia

时间窗: regular intervals intra operatively and post operatively

次要结局

  • duration of analgesia early mobilization early discharge from hospital(end operative 6hr 12hr 24hr postop)

研究者

发起方
Rajiv Gandhi institute of Medical Sciences Adilabad Telangana
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shirley Stephen

Rajiv Gandhi institute of Medical Sciences Adilabad Telangana

研究点 (1)

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