| CTRI Number |
CTRI/2025/09/094658 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to assess the effect of the addition of dexamethasone (a steroid drug) to commonly used pain killers, on the pain relief after keyhole surgery for oesophageal cancer at a cancer institute. |
|
Scientific Title of Study
|
A prospective double-blinded randomised controlled study to assess the safety and efficacy of dexamethasone in post-operative multimodal analgesia after minimally invasive esophagectomy at a tertiary care cancer centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4856_Version 2.0 dated 08.08.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnil Y Parab |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesiology, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9819319866 |
| Fax |
|
| Email |
swapnil.parab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Y Parab |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesiology, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9819319866 |
| Fax |
|
| Email |
swapnil.parab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indulekha Menon |
| Designation |
Post graduate student |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesiology, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9400670433 |
| Fax |
|
| Email |
menonindulekha97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Research Administrative Council, 2rd floor, Main building, Tata Memorial Hospital, Mumbai, India-400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital, Mumbai, India |
| Address |
E. Borges Road, Parel, Mumbai, India. Pin-400012 |
| 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 |
| Dr Swapnil Parab |
Tata Memorial Hospital, Mumbai |
Major OT complex, 2nd floor, Main Building, Tata Memorial Hospital, Mumbai, India
Mumbai
MAHARASHTRA |
022-24177053
swapnil.parab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TATA MEMORIAL HOSPITAL INSTITUTIONAL ETHICS COMMITTEE I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
The study arm will receive dexamethasone 6 mg or 0.1mg/kg, whichever is lower, diluted up to two millilitres by normal saline within one hour of induction. |
| Comparator Agent |
placebo drug (Normal saline) |
The patient in the control arm will receive the first dose of the placebo drug, 2 millilitres of normal saline, within one hour of induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 80 years undergoing minimally invasive oesophagectomy (Video Assisted Thoracoscopic Surgery / Robotic) |
|
| ExclusionCriteria |
| Details |
1. Contraindications to Dexamethasone-
a) Diabetic patients with HbA1c more than 6, patients requiring insulin therapy
b) Patients with evidence of preoperative infection suggested by fever, radiological signs suggestive of infection in the chest, deranged CRP, PCT, WBC more than 11,000 or less than 4000.
c) Patients on chronic steroid therapy.
2. Chronic therapy with opioids, drug addiction, or a history of drug abuse.
3. Contraindications to diclofenac-
a) Deranged Renal function suggested by past history of Acute Kidney Injury / Chronic Kidney Disease, with serum creatinine 1. Contraindications to Dexamethasone-
a) Diabetic patients with HbA1c more than 6, patients requiring insulin therapy
b) Patients with evidence of preoperative infection suggested by fever, radiological signs suggestive of infection in the chest, deranged CRP, PCT, WBC more than 11,000 or less than 4000.
c) Patients on chronic steroid therapy.
2. Chronic therapy with opioids, drug addiction, or a history of drug abuse.
3. Contraindications to diclofenac-
a) Deranged Renal function suggested by past history of Acute Kidney Injury / Chronic Kidney Disease, with serum creatinine more than 1.5 mg percent and /or requiring dialysis/ Renal replacement Therapy,
b) Deranged renal function tests –serum creatinine value more than 1.5mg / dl
c) Patients with low platelet counts ( less than 75,000 per microlitre)
d) Patients with a history of peptic ulcer disease,
e) Patients with pre-existing susceptibility to Aspirin-induced Bronchial asthma.
4. Contraindication to Paracetamol -liver dysfunction- Child – Pugh – Turcotte score of class B (value 7 – 9 ) and above, indicating moderately impaired hepatic function
1.5 mg percent and /or requiring dialysis/ Renal replacement Therapy,
b) Deranged renal function tests –serum creatinine value more than 1.5mg / dl
c) Patients with low platelet counts ( less than 75,000 per microlitre)
d) Patients with a history of peptic ulcer disease,
e) Patients with pre-existing susceptibility to Aspirin-induced Bronchial asthma.
4. Contraindication to Paracetamol -liver dysfunction- Child – Pugh – Turcotte score of class B (value 7 – 9 ) and above, indicating moderately impaired hepatic function
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate the total opioid consumption (in terms of morphine equivalents) in the post operative period |
First 48 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Rating Scale (0-10) for pain at rest ( NRS REST), Numeric Rating Scale after exercise ( NRS EXERCISE ), Maximum inspiratory efforts on spirometer at predefined time intervals |
1-4 hours, 4-8 hours, 8-12 hours, 20-24 hours, 30-36 hours and 44- 48 hours after the surgery |
| The worst pain NRS |
at 24 hours and 48 hours |
| Episodes of hyperglycaemia (blood sugar levels above 180 mg/dl) |
up to 48 hours |
| Episodes of post-operative nausea, vomiting |
Till 48 hours post surgery |
Incidence of –
Surgical wound infection
Infective pulmonary complications
Anastomotic leak
Status of the patient
CLVIEN DINDO score
|
Till hospital discharge |
|
|
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)
|
29/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 a prospective, double-blinded, phase II randomised
controlled trial being done to evaluate the safety and efficacy of
dexamethasone as a multimodal analgesic in minimally invasive esophagectomy in esophageal cancer patients . Patients
included in the study will be randomised into two groups: one receiving
dexamethasone as an adjunct to standard multimodal analgesia, and the other
receiving placebo [ normal saline ] with standard care as per Institutional
practice. All the patients will be provided with Fentanyl PCA in the post
operative period for 48 hours post surgery
The primary outcome will be to calculate the total opioid consumption in
the first 48 hours after surgery in terms of morphine equivalents.
Secondary endpoints will include pain scores assessment pre determined time intervals ,
incidence of postoperative nausea and vomiting, hyperglycemia and safety
parameters such as wound healing complications, infections, and anastomotic
leak.
The trial will follow Good Clinical Practice guidelines,
with appropriate safety monitoring and interim analyses. Findings are expected
to clarify whether dexamethasone provides a safe and effective enhancement to
multimodal pain management after minimally invasive esophagectomy in a cancer
care setting. |