| CTRI Number |
CTRI/2022/10/046752 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
26/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Intravenous Versus Inhalational Anaesthetic agent on Oxygenation in Patients undergoing Thoracic Surgery
|
|
Scientific Title of Study
|
Effect of Propofol Total Intravenous versus Sevoflurane Inhalational General Anaesthesia on Arterial Oxygenation
During One-Lung Ventilation in Patients undergoing Open
Thoracic Surgery:
A Randomized Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadia Ahmad |
| Designation |
DNB Trainee |
| Affiliation |
Sir Gangaram Hospital, New Delhi |
| Address |
Sir Gangaram Hospital, Rajinder Nagar, New Delhi 110060
Central
DELHI
110060
India |
| Phone |
9538035310 |
| Fax |
|
| Email |
ahmad.nadia24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Sood |
| Designation |
Head of Department |
| Affiliation |
Sir Gangaram Hospital, New Delhi |
| Address |
Rajinder Nagar, New Delhi 110060
Central
DELHI
110060
India |
| Phone |
9811294608 |
| Fax |
|
| Email |
drjayashreesood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nadia Ahmad |
| Designation |
DNB Trainee |
| Affiliation |
Sir Gangaram Hospital, New Delhi |
| Address |
Sir Gangaram Hospital, Rajinder Nagar, New Delhi 110060
Central
DELHI
110060
India |
| Phone |
9538035310 |
| Fax |
|
| Email |
ahmad.nadia24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Gangaram Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Gangaram Hospital |
| Address |
Sir Gangaram Hospital, Rajinder Nagar, New Delhi 110060 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nadia Ahmad |
Sir Gangaram Hospital |
OT Complex 6th floor, SSRB Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi 110060
Central
DELHI |
9538035310
ahmad.nadia24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee, SGRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J869||Pyothorax without fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inhalational Agent |
Sevoflurane Titrated to Maintain BIS between 40-60 |
| Comparator Agent |
NA |
NA |
| Intervention |
Total Intravenous Anaesthesia |
Infusion of Propofol 2% to Maintain BIS Between 40-60 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Age of patient between 18-70 years.
2 All consenting patients to undergo open thoracic surgery.
3 American Society of Anaesthesiologist (ASA) physical status between 1-3.
4 Patients with unilateral lung pathology undergoing thoracic surgery.
|
|
| ExclusionCriteria |
| Details |
1 Patients with bilateral pulmonary pathology.
2 Patients with baseline SpO2 < 90% at room air.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Arterial Oxygenation PaO2 by serial ABG, in both the groups. |
ABG to be taken at 5 predetermined time points, that is at 10 minutes of Two-lung ventilation after induction, then at 15,30,60 and 90 minutes after the start of One-lung ventilation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Cardiac Output and Stroke Volume |
10 minutes of Two-lung ventilation, then at 15,30,60 and 90 minutes after the start of One-lung ventilation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/10/2022 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not at this time |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intravenous propofol and various inhalational anaesthetic agents are the key components of modern general anaesthesia. Advances in thoracic surgery have been possible with the use of these modern anaesthetic agents. One lung ventilation (OLV) is indicated for thoracic surgical procedures, for prevention of cross-contamination of the lungs and to control the distribution of ventilation. However, during OLV, hypoxemia remains a major concern in the management of anaesthesia for thoracic surgery, due to pulmonary arteriovenous shunting of unsaturated pulmonary venous blood. Hypoxic pulmonary vasoconstriction acts as a defence mechanism against shunting. Therefore, in thoracic surgery, anaesthetics with minimal inhibitory effect on HPV and minimal haemodynamic changes are preferred. By limiting intrapulmonary shunting, the fall in arterial oxygen pressure can be attenuated, thus allowing better patient outcome. This randomized study aims to evaluate the effect of two major anaesthetic agents, propofol and sevoflurane on arterial oxygenation during one lung ventilation in adults undergoing elective right sided open thoracic surgery. |