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CTRI Number  CTRI/2025/01/079501 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Need for Perioperative steroid administration in patients undergoing Endoscopic transsphenoidal resection of pituitary adenoma 
Scientific Title of Study   Perioperative steroid administration versus no steroid administration in patients with intact hypothalamic-pituitary axis undergoing Endoscopic transsphenoidal resection of pituitary adenoma: A randomized control 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  Karthik J S 
Designation  Senior Resident 
Affiliation  AIIMS Jodhpur 
Address  Dr Karthik J S Senior Resident M.Ch (Neurosurgery) Department of Neurosurgery AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9901568322  
Fax    
Email  dr.karthikjs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jaskaran Singh Gosal 
Designation  Associate Professor 
Affiliation  AIIMS Jodhpur 
Address  Department of Neurosurgery AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  6283475891  
Fax    
Email  jhsgosal_87@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Jaskaran Singh Gosal 
Designation  Associate Professor 
Affiliation  AIIMS Jodhpur 
Address  Department of Neurosurgery AIIMS Jodhpur


RAJASTHAN
342005
India 
Phone  6283475891  
Fax    
Email  jhsgosal_87@hotmail.com  
 
Source of Monetary or Material Support  
Department of Neurosurgery, AIIMS Jodhpur, Rajasthan 342005. 
 
Primary Sponsor  
Name  Department of Neurosurgery AIIMS Jodhpur 
Address  Department of Neurosurgery AIIMS Jodhpur 342005 Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karthik J S  AIIMS Jodhpur  Department of Neurosurgery, AIIMS Jodhpur, Rajasthan 342005.
Jodhpur
RAJASTHAN 		 9901568322

dr.karthikjs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E349||Endocrine disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NOSTEROID (Placebo/ Inj 0.9%/Normal Saline)  Those not receiving perioperative hydrocortisone replacement. The NOSTEROID will receive no hydrocortisone before, during, or after surgery. In case of adrenal insufficiency during the perioperative period the patient is managed by immediate hemodynamic stabilization, and steroid supplementation. Inj hydrocortisone 100 mg intravenous bolus followed by 50 mg intravenously every 6 hours or 200 mg for 24 hours as a continuous intravenous infusion for the first 24 hours. Parenteral glucocorticoid are tapered over 1 to 3 days, if precipitating or complicating illness persist, to oral glucocorticoid maintenance dose. 
Comparator Agent  STEROID (Inj Hydrocortisone)  Those receiving perioperative hydrocortisone replacement. The STEROID group will receive perioperative hydrocortisone replacement according to protocol. Inj Hydrocortisone 100mg iv stat at time of induction of anesthesia Inj Hydrocortisone 10mg/hr iv x 1 day Inj Hydrocortisone 50mg iv q 8hrly x 1 day Inj Hydrocortisone 50mg iv q 12hrly x 1 day Inj Hydrocortisone 25mg iv q 12hrly x 1 day Tab Wysolone 5mg OD, patient to be followed up for further evaluation and dose modification as required. 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Pituitary adenoma requiring endoscopic transsphenoidal surgical resection
2 Intact HPA axis 
 
ExclusionCriteria 
Details  1 Patients with preoperative adrenal insufficiency or Cushings Disease
2 Patients on steroids for other systemic illnesses
3 Patients on drugs that could affect the HPA axis
4 Patients refusing consent for surgery/study.
5 Pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To compare the perioperative serum cortisol levels and
2. The incidence of adrenal insufficiency postoperatively after endoscopic trans nasal resection in patients of pituitary adenoma with an intact hypothalamic-pituitary-adrenal (HPA) axis during the 1st three postoperative days for the primary outcome 		 Preoperative period
Post operative day 1
Post operative day 2 
 
Secondary Outcome  
Outcome  TimePoints 
The incidence of adrenal insufficiency postoperatively
after endoscopic transnasal resection in patients of pituitary adenoma with an
intact hypothalamic-pituitary-adrenal (HPA) axis during 1st 3 months postoperatively for secondary outcome 		 3 months after endoscopic transnasal resection in patients of pituitary adenoma 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   04/02/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. 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

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.karthikjs@gmail.com].

  6. For how long will this data be available start date provided 31-12-2027 and end date provided 31-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Hypothesis Patients undergoing pituitary adenoma surgery are given perioperative Stress dose Hydrocortisone replacement  therapy. This perioperative replacement can be safely avoided given the myriad of side effects of steroids in patients with intact HPA axis function

Research questions Will the incidence of new-onset Adrenal insufficiency in the postoperative period be affected by the withholding of perioperative hydrocortisone replacement therapy as compared to those receiving hydrocortisone replacement therapy

Aims and Objectives

Aim To assess if perioperative hydrocortisone supplementation can be avoided in patients with an intact hypothalamus pituitary adrenal (HPA) axis for pituitary adenoma via endoscopic trans nasal resection

Objective:
1 To compare the perioperative serum cortisol levels.
2 The incidence of adrenal insufficiency postoperatively after endoscopic trans nasal resection in patients of pituitary adenoma with an intact hypothalamic pituitary adrenal or HPA axis during the 1st three postoperative days for the primary outcome and the 1st 3 months postoperatively for secondary outcome
 
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