| CTRI Number |
CTRI/2024/02/062705 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of postoperative lung functions and outcomes of general anaesthesia with regional anaesthesia versus regional anaesthesia alone in patients undergoing major open abdominal surgeries: an exploratory randomized study |
|
Scientific Title of Study
|
Comparison of postoperative pulmonary functions and outcomes in patients undergoing major open abdominal surgeries between general anaesthesia with thoracic epidural and thoracic continuous spinal anaesthesia: an exploratory randomized study |
| 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 Gourav Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7351941828 |
| Fax |
|
| Email |
gourav.kumar9795@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Additional professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Additional professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh Hospital Resources |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh
Veerbhadra road, Rishikesh
249203 |
| Type of Sponsor |
Government 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 Gourav Kumar |
AIIMS Rishikesh |
Department of Anaesthesiology
AIIMS Rishikesh
249203
Dehradun
UTTARANCHAL |
7351941828
gourav.kumar9795@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh Institutional 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 |
| Comparator Agent |
General anaesthesia with Thoracic epidural Catheter |
Thoracic epidural catheter will be first inserted in T9 and T10 intervertebral space and patient would be induced under General anaesthesia for major open abdominal surgeries. General anaesthesia would be induced after preoxygenating the patient with 100% oxygen for 3 minutes, intravenous induction with fentanyl (2mcg/kg), propofol (2-3mg/kg) and vecuronium (0.1mg/kg). Appropriate size endotracheal tube would be used for securing the airway. Mechanical ventilation during the operation would be done with tidal volume (TV) of 8 ml/kg of predicted body weight (PBW) with PEEP of 5 to 8 cm of H2O and respiratory rate (RR) to be adjusted to keep end tidal CO2 between 35-45 mm of Hg. Sevoflurane (1.5%-3.0%, to maintain MAC of 1.0) with O2:air (50:50) will be used as a maintenance agent along with vecuronium during the surgery.
post operatively continuous epidural infusion would be started with 0.0625% of levobupivacaine along with 2mcg/ml of fentanyl for 72 hours. |
| Intervention |
Thoracic Continuous Spinal Anaesthesia |
Continuous spinal catheter of 24G or 25G will be inserted in T9 andT10 intervertebral space and 0.5mL bolus doses of isobaric levobupivacaine 0.5% every 3 minutes along with fentanyl 0.3mcg/kg would be injected in the intrathecal space to achieve sensory block from T4 to L1 dermatome level before starting of surgery. The dose required to reach T4-L1 would be noted and continuous infusion will be started at beginning of the surgery at the same dose intraoperatively. Motor blockade would be assessed using modified bromage scale at the start of surgery. IV sedation SOS will be started with dexmedetomidine infusion 0.2-0.7 mcg/kg/min and patient’s sedation level will be kept between Ramsay sedation score 2-3. Post operatively continuous infusion will be started through elastomeric pump connected to the intrathecal catheter at the rate of 8mg/hour of lignocaine with 8mcg/hour of fentanyl for the first 24 hours after the surgery and then 4mg/hour of lignocaine with 4 mcg/hour of fentanyl for the next 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18years
Both genders
ASA physical status I-III
Patient undergoing Elective major abdominal surgery
|
|
| ExclusionCriteria |
| Details |
Refusal by the patient
Any contraindication to Thoracic Epidural Anaesthesia and Thoracic Continuous Spinal Anaesthesia
Emergency surgery
Abdominal trauma patient
Expected severe hemodynamic instability (pheochromocytoma)
Pregnant females
BMI more than 35
Severe systemic disease (ASA physical status IV)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the peak expiratory flow rate assessed using hand held spirometer at predefined time points |
preoperative (T0)
immediate postoperative (T1) post operative day 1 (T2)
post operative day 2 (T3)
post operative day 3 (T4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare breath holding time and SpO2 at predefined time points |
preoperative (T0)
immediate postoperative (T1) post operative day 1 (T2)
post operative day 2 (T3)
post operative day 3 (T4) |
| To compare the incidence of postoperative lung atelectasis (ultrasound assessed) at predefined time points |
preoperative (T0)
immediate postoperative (T1) post operative day 1 (T2)
post operative day 2 (T3)
post operative day 3 (T4) |
| To compare the incidence of other postoperative pulmonary complications (pleural effusion, pneumonia, pneumothorax, acute respiratory distress syndrome) |
preoperative (T0)
immediate postoperative (T1) post operative day 1 (T2)
post operative day 2 (T3)
post operative day 3 (T4) |
| To compare postoperative change in trans-diaphragmatic excursion (ultrasound assessed Delta TDI) at predefined time points |
preoperative (T0)
immediate postoperative (T1) post operative day 1 (T2)
post operative day 2 (T3)
post operative day 3 (T4) |
| To compare all cause in-hospital mortality in patients receiving general anaesthesia plus thoracic epidural versus thoracic continuous spinal anaesthesia |
throughout the hospital stay of the patient |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2024 |
| 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="6"
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 - NO
|
|
Brief Summary
|
This is an exploratory randomized, single blinded, parallel group study to compare post operative pulmonary functions and outcomes in patients receiving General anaesthesia with Thoracic epidural versus Thoracic continuous spinal anaesthesia for major open abdominal surgeries that will be conducted in India. The hypothesis is that the pre operative pulmonary functions would be better preserved in regional anaesthesia (thoracic continuous spinal anaesthesia) as compared to general anaesthesia in patients undergoing major abdominal surgeries. Hence, better postoperative pulmonary functions and outcomes in regional anaesthesia. The primary objective would be to compare peak expiratory flow rate at predefined time intervals [preoperative (T0), immediate postoperative (T1), post operative day 1 (T2), post operative day 2 (T3), post operative day 3 (T4)]. The secondary objectives would be to compare breath holding time and SpO2, incidence of postoperative lung atelectasis (ultrasound assessed), incidence of other postoperative pulmonary complications (pleural effusion, pneumonia, pneumothorax, acute respiratory distress syndrome), change in trans-diaphragmatic excursion (ultrasound assessed Delta TDI) at predefined time points [preoperative (T0), immediate postoperative (T1), post operative day 1 (T2), post operative day 2 (T3), post operative day 3 (T4)] and all cause in-hospital mortality. |