| CTRI Number |
CTRI/2024/10/074990 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early recovery of patients who need general anaesthesia for laparoscopic surgeries using desflurane gas. |
|
Scientific Title of Study
|
Fast track anaesthesia with desflurane in adult patients undergoing gastrointestinal (laparoscopic) surgeries – A study of 50 cases. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejash H Sharma |
| Designation |
Professor |
| Affiliation |
Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Dept of Anaesthesiology, 3rd floor, Dhiraj Hospital, Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University, Piparia, Ta Waghodiya
B 15 Shyam Residency, TP 13, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9427332100 |
| Fax |
|
| Email |
drtejash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejash H Sharma |
| Designation |
Professor |
| Affiliation |
Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Dept of Anaesthesiology, 3rd floor, Dhiraj Hospital, Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University, Piparia, Ta Waghodiya
B 15 Shyam Residency, TP 13, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9427332100 |
| Fax |
|
| Email |
drtejash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejash H Sharma |
| Designation |
Professor |
| Affiliation |
Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Dept of Anaesthesiology, 3rd floor, Dhiraj Hospital, Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University, Piparia, Ta Waghodiya
B 15 Shyam Residency, TP 13, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9427332100 |
| Fax |
|
| Email |
drtejash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumandeep Vidyapeeth Deemed to be University, Piparia, Ta- Waghodiya, Vadodara, 391760 Gujarat,India. |
|
|
Primary Sponsor
|
| Name |
Sumandeep Vidyapeeth |
| Address |
Sumandeep Vidyapeeth Deemed to be University, Piparia, Ta- Waghodia 391760 Vadodara, Gujarat, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tejash H Sharma |
Dhiraj Hospital |
Dept. of Anaesthesiology, Dhiraj Hospital, Sumandeep Vidyapeeth Deemed to be University, Piparia, Ta- Waghodiya, 391760, Vadodara, Gujarat,
Vadodara
GUJARAT |
9427332100
drtejash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Intitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.). |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To monitor mean time for extubation after stopping inhalational agent |
Post extubation White’s fast track scoring will be done at 1 minute interval till the score will be ≥ 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
Side effects or complications if any. |
Hemodynamics will be recorded immediately after tracheal intubation, at skin incision & 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 more than or equal to 12. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - drtejash@gmail.com
- For how long will this data be available start date provided 07-12-2025 and end date provided 12-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
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. |