| CTRI Number |
CTRI/2025/08/093867 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of dexamethasone on quality
of recovery in patients undergoing surgery for gastrointestinal
and hepato-pancreato-biliary malignancy- Randomized
controlled trial |
|
Scientific Title of Study
|
Impact of preoperative dexamethasone versus placebo on quality
of recovery in patients undergoing surgery for gastrointestinal
and hepato-pancreato-biliary malignancy- Randomized
controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Agarwal |
| Designation |
Senior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Surgical Gastroenterology ,Block C, Level 3
Academic building,AIIMS Campus, Veerbhadra road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8564849303 |
| Fax |
|
| Email |
shubhamagarwal.dr7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lokesh Arora |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Surgical Gastroenterology ,Block C, Level 3
Academic building,AIIMS Campus, Veerbhadra road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8564849303 |
| Fax |
|
| Email |
lokesharora1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Agarwal |
| Designation |
Senior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Surgical Gastroenterology ,Block C, Level 3
Academic building,AIIMS Campus, Veerbhadra road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8564849303 |
| Fax |
|
| Email |
shubhamagarwal.dr7@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences , Veerbhadra road,Rishikesh ,Dehradun 249203 |
|
|
Primary Sponsor
|
| Name |
Aiims Rishikesh |
| Address |
Virbhadra road, rishikesh ,249203 |
| 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 |
| shubham agarwal |
Aiims Rishikesh |
Virbhadra road, rishikesh
Dehradun
UTTARANCHAL |
8564849303
shubhamagarwal.dr7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee , All India Institute Of medical Sciences ,Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (2) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (3) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (4) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (5) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (6) ICD-10 Condition: C20||Malignant neoplasm of rectum, (7) ICD-10 Condition: C210||Malignant neoplasm of anus, unspecified, (8) ICD-10 Condition: C229||Malignant neoplasm of liver, not specified as primary or secondary, (9) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (10) ICD-10 Condition: C249||Malignant neoplasm of biliary tract, unspecified, (11) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (12) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJECTION DEXAMETHASONE |
patient will be given one time - 8mg dexamethasone via intravenous route diluted in 100ml normal saline induction of anesthesia and before the start of surgery. |
| Comparator Agent |
placebo |
group will be given 100ml normal saline after the time of induction of anesthesia and before the start of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Patients undergoing curative intent elective surgery for gastrointestinal malignancy
• ECOG 0-2
• Written, informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of preoperative dexamethasone on quality of recovery in patients undergoing surgery for GI and HPB malignancy (using QOR-40 score) |
post operative day 3
post operative day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| length of Intensive care Unit stay |
|
| 30 day morbidity |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/09/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Postoperative systemic inflammatory-immune dysregulation is a key component of the body’s response to surgical injury, increasing the risk of complications and leading to extended hospital stays. Perioperative glucocorticoid can suppress this response, thereby reducing complication and enhancing post-operative recovery One of the primary mechanisms of glucocorticoids is their ability to suppress inflammation. They inhibit the transcription of key pro-inflammatory transcription factors such as AP-1, NF-kB, and STAT3, which leads to a reduction in the production of pro-inflammatory cytokines.However, the use of glucocorticoid in improving the post operative quality of recovery among patients of gastrointestinal malignancy (GI) and hepato pancreto-biliary(HPB) malignancy is limited.
Numerous article report safety of glucocorticoids and their use for postoperative nausea, vomiting and pain. Most studies report that their use reduces the post operative complication without increasing blood sugar level and risk of surgical site infection. However no study directly examine the effect of preoperative dexamethasone on improving quality of recovery in patient of GI and HPB malignancy after curative surgery. Therefore, aim of the study is to assess the impact of preoperative dexamethasone versus placebo on quality of recovery in patients undergoing surgery for gastrointestinal(GI) and hepato-pancreato-biliary (HPB) malignancy
|