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Effectiveness of anaesthetic liquid vapour sevoflurane and desflurane from awakening under complete sleep anaesthesia in patients undergoing key hole gall blader operation patients in Regional Institute of Medical Sciences Hospital using randomly selection of patients.

Not Applicable
Not yet recruiting
Conditions
Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,
Registration Number
CTRI/2024/01/061925
Lead Sponsor
Regional Institute of Medical Sciences
Brief Summary

Sevoflurane and desflurane are the newer inhalational volatile anaesthetics with properties close to ideal and have been an important agent used in the maintenance of anesthesia. Some previous studies have highlighted that desflurane provided rapid and stable emergence than sevoflurane in many surgical day care procedures. Desflurane however has been not used in induction due to its propensity to cause airway irritation, cough, larngospasm and profuse secretion in some studies.  Laparoscopic cholecystectomy surgery is usually a minimal invasive one which offers reduced morbidities, lesser operative time and early return to normal activities.

The present study will be conducted to compare the recovery characteristics of sevoflurane and desflurane in laparoscopic cholecystectomy under general anaesthesia and will compare the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach  modified Aldrete score of 9. The study has been planned as there is paucity of literatures comparing these two agents on laparoscopic cholecystectomy which is the most common operative procedure in the Institute and it has also not been undertaken in this part of our ethinicity

A total of 60 patients, aged 18 to 55 years belonging to American society of Anaesthesiologists (ASA) I and II, undergoing laparoscopic cholecystectomy under general anaesthesia will be divided into two groups (Group A and Group B) by block randomization. Group A patients will receive Sevoflurane as maintenance agent with concentration decided by Bispectral Index Score (BIS) and hemodynamics parameters whlie Group B patients will receive Desflurane as maintenance agent with concentration decided by Bispectral Index Score (BIS) and hemodynamics parameters.The time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach  modified Aldrete score of 9 will be recorded in minutes.The hemodynamics parameters such as blood pressure and heart rate at 5 minutes, 10th minutesthereafter for every 10 minutes and at immediate postoperative period, side effects such as coughing, emergence agitation, nausea and vomiting, laryngospasm, excessive secretion, desaturation, etc will also be assessed.

The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference will be drawn. The study will be conducted after getting due approval from the Research Ethics Board of the Institute and after registration with the Clinical Trial Registry of India.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

1.Patients of both sex with American Society of Anesthesiologist (ASA) physical grade I or II 2.Patients of age group 18 to 55 years of Manipuri ethnicity undergoing laparoscopic cholecystectomy under general anaesthesia.

Exclusion Criteria
  • 1.History of use of hypnotics or antipsychotics in the last 30 days 2.History of cerebrovascular diseases, chronic kidney diseases, significant cardiovascular diseases, chronic obstructive pulmonary diseases, etc.
  • 3.Pregnant patient, patient refusal and history of allergy to any medication 4.Surgeries lasting more than one hour.
  • 5.Body mass index more than 30.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome of this study will be the time interval from the stoppage of inhalational anaesthetics to the time to spontaneous eye opening, time to obey commands, time to extubation and time to reach modified Aldrete score of 9.The assesment will be done from the stoppage of inhalational anaesthetic to spontaneous recovery, i.e at 5 and 10 minutes after the stoppage.
Secondary Outcome Measures
NameTimeMethod
The secondary outcomes will includehemodynamics parameters such as blood pressure and heart rate at 5 minutes, 10th minutes, thereafter for every 10 minutes and also at immediate postoperative period, side effects such as coughing, emergence agitation, nausea and vomiting, laryngospasm, excessive secretion, desaturation, etcThe recording will be done at 5th, 10th, every 10 minutes intraoperatively and immediate postoperative

Trial Locations

Locations (1)

Regional Institute of Medical Sciences

🇮🇳

West, MANIPUR, India

Regional Institute of Medical Sciences
🇮🇳West, MANIPUR, India
Dr Takhelmayum Hemjit Singh
Principal investigator
09436021445
takhelhem@yahoo.com

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