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CTRI Number  CTRI/2022/03/041234 [Registered on: 21/03/2022] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Will steam inhalation of drug dexmedetomidine before surgery improve surgery conditions, control BP and heart rate during anesthesia breathing tube placement and surgery as compared to steam inhaled combination dexmedetomidine-lignocaine and saline in pituitary surgery through nose route. 
Scientific Title of Study   A comparative evaluation of preoperative nebulized dexmedetomidine, nebulized dexmedetomidine - lignocaine combination and nebulized saline on surgical field clarity and hemodynamic fluctuations during transnasal transsphenoidal pituitary tumour surgery and their ability to blunt intubation response-A RANDOMISED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranganatha Praveen C S 
Designation  Associate Professor 
Affiliation  SCTIMST,Trivandrum 
Address  Associate Professor, department of Anesthesiology, Neuroanesthesia division,Sree Chitra Tirunal Institute for Medical Sciences and Technology(SCTIMST) Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9855746254  
Fax    
Email  drrpcs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ranganatha Praveen C S 
Designation  Associate Professor 
Affiliation  SCTIMST,Trivandrum 
Address  Associate Professor, department of Anesthesiology, Neuroanesthesia division,Sree Chitra Tirunal Institute for Medical Sciences and Technology(SCTIMST) Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9855746254  
Fax    
Email  drrpcs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ranganatha Praveen C S 
Designation  Associate Professor 
Affiliation  SCTIMST,Trivandrum 
Address  Associate Professor, department of Anesthesiology, Neuroanesthesia Division,Sree Chitra Tirunal Institute for Medical Sciences and Technology(SCTIMST) Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9855746254  
Fax    
Email  drrpcs@gmail.com  
 
Source of Monetary or Material Support  
SCTIMST,Trivandrum 
 
Primary Sponsor  
Name  Dr Ranganatha Praveen C S 
Address  SCTIMST,Trivandrum 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ajay Prasad Hrishi  SCTIMST,Trivandrum 
Dr Manikandan Sethuraman   SCTIMST, Trivandrum 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ranganatha Praveen C S  Sree Chitra Tirunal Institute for Medical Sciences and Technology  Department of Anesthesiology, Neuroanesthesia division
Thiruvananthapuram
KERALA 		 9855746254

drrpcs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,SCTIMST,Trivandrum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E230||Hypopituitarism, (2) ICD-10 Condition: E240||Pituitary-dependent Cushings disease, (3) ICD-10 Condition: E220||Acromegaly and pituitary gigantism, (4) ICD-10 Condition: E221||Hyperprolactinemia, (5) ICD-10 Condition: E236||Other disorders of pituitary gland,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine, lignocaine, normal saline  Arm 1 : nebulization of Dexmedetomidine at a dose of 1.5 μg/kg mixed with 2% lignocaine to a total volume of 5 ml. Arm 2 : nebulization of Dexmedetomidine at a dose of 1.5 μg/kg mixed with saline to a total volume of 5 ml Arm 3 : nebulization of 5ml of saline  
Comparator Agent  nebulized dexmedetomidine  dose of 1.5 μg/kg mixed with saline to a total volume of 5 ml, preoperative single time use 
Comparator Agent  nebulized dexmedetomidine with lignocaine  Dexmedetomidine at a dose of 1.5 μg/kg mixed with 2% lignocaine to a total volume of 5 ml,preoperative single use 
Comparator Agent  nebulized normal saline (placebo)  5ml of saline, preoperative single use 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA (American Society of Anaesthesiology) 1 and 2
Surgery for pituitary tumors via Transnasal trans sphenoidal surgery (TNTS) route
Glasgow Coma Score(GCS) 15
Cushings and Acromegaly without cardiac abnormality
 
 
ExclusionCriteria 
Details  GCS <15
Raised ICP(Intracranial pressure)
Pregnant & nursing mothers, patients < 18 years or more than 60 years.
Pituitary apoplexy, Cushings and acromegaly with cardiac abnormality.
ASA (American Society of Anaesthesiology) 3,4 and 5
Concomitant severe medical illness like decompensated heart failure, advanced liver disease, renal failure. History of allergy and previous nasal surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of nebulized dexmedetomidine-lignocaine combination, nebulized dex-medetomidine in saline and nebulized saline alone on intra operative surgical conditions and hemodynamic fluctuations in TNTS pituitary surgery  Surgical field assesment-Beginning of surgery, every 15 minutes from start of surgery till the tumour is reached. Hemodynamic assessment-Baseline,Beginning of surgery,every minute after packing soaked adrenaline gauze, at insertion of the endoscope and 3 minutes later, at the start of mucosal dissection and then every minute for 5 minutes, every 10 minutes for 1 hour, half- hourly for subsequent hours during surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effects of nebulized dexmedetomidine-lignocaine combination, nebulized dex-medetomidine in saline and nebulized saline alone on Hemodynamic responses to intubation, extubation, post operative pain, post operative throat discomfort due to throat pack and total Propofol/fentanyl/labetalol use.  Haemodynamics- Baseline, after nebulisation,intubation, immediately post intubation and every minute for next 5 minutes and every 2 minutes for next 5 minutes upto 10 minutes after intubation, at extubation and 5minutes after extubation.All these time points are done in the operation theatre.Total anesthetic agents used at different stages will be individually calculated at the end of the surgery.
Post operative pain and throat discomfort-assessed within 24 hrs following surgery. 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   28/03/2022 
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="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   There is no publication presently on the above topic. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   In this prospective randomised control study we attempt to investigate the role of nebulized dexmedetomidine, combination of nebulized dexmedetomidine and lignocaine in improving the surgical field and blunting the hemodynamic response to local adrenaline nasal packing,intubation,achieveing optimal hemodynamic profile throughout the procedure and effect on postoperative pain and sore throat in transnasal transsphenoidal pituitary tumour surgery.It is based on the local vasoconstriction, sympatholytic and analgesic property of dexmedetomidine with no side effects of its intravenous route.Dexmedetomidine and its combination with lignocaine nebulization is safely reported to have been used for awake fibreoptic intubation.Also nebulized dexmedetomidine is found to blunt intubation response and also safely used for pediatric sedation(the dose which we intend to use is used safely in the mentioned areas).However nebulized dexmedetomidine or its combination with lignocaine is not used for transnasal pituitary surgeries till date while intravenous dexmedetomidine is used for the purpose but has side effects in intravenous dose(bradycardia,hypotension), which became the impetus of our study.

 
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