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CTRI Number  CTRI/2025/07/091503 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of two drugs (Nalbuphine- yo reliev pain and dexmedetomidine- to treat pain) for post operative pain in FESS (Functional endoscopic sinus surgery) ent surgery 
Scientific Title of Study   COMPARISON OF NALBUPHINE VS DEXMEDETOMIDINE FOR POST OPERATIVE PAIN IN FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Morampudi kavyasri  
Designation  Post graduate 
Affiliation  Sree balaji medical college and hospital  
Address  Sree balaji medical college and hospital, clc works , chromepet , chennai

Chennai
TAMIL NADU
600044
India 
Phone  8106764497  
Fax    
Email  Kavyasri.21798@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kala B 
Designation  Professor , Dept of Anaesthesiology 
Affiliation  Sree Balaji Medical college and hospital 
Address  1st floor , professor/ chief room , Sree balaji medical college and hospital, clc works , chromepet , chennai

Chennai
TAMIL NADU
600044
India 
Phone  9444680908  
Fax    
Email  kalamhn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Morampudi kavyasri  
Designation  Post graduate 
Affiliation  Sree balaji medical college and hospital  
Address  Sree balaji medical college and hospital, clc works , chromepet , chennai


TAMIL NADU
600044
India 
Phone  8106764497  
Fax    
Email  Kavyasri.21798@gmail.com  
 
Source of Monetary or Material Support  
Sree Balaji Medical College , CLC works road , Chromepet , Chennai , India , 600044 
 
Primary Sponsor  
Name  Sree Balaji medical college and hospital 
Address  Department of anaesthesiology , Sree Balaji medical college and hospital, clc works road, chromepet, chennai, India . 600044 
Type of Sponsor  Private 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 
Morampudi kavyasri   Sree Balaji medical college and hospital  clc works, chromepet, chennai, India , 600044
Chennai
TAMIL NADU 
8106764497

Kavyasri.21798@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee sree balaji medical college and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J010||Acute maxillary sinusitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Asa 1 and 2 patients , who have given consent  
 
ExclusionCriteria 
Details  Asa3 and 4 , patients who have not given consent , patients with chronic pain. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Valbuphine will be a better for post-operative pain in FESS pts compared
to Dexmedetomidine 
Valbuphine will be a better for post-operative pain in FESS pts compared
to Dexmedetomidine 
 
Secondary Outcome  
Outcome  TimePoints 
hemodynamic stability of patients in both the groups
during the perioperative periods . 
Post operatively pain score will be assessed every 1hr till post operative day 1 
 
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)   01/08/2025 
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="0"
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 - NO
Brief Summary   Functinal endoscopic sinus surgery (FESS) is a common treatment for
chronic sinusitis, nasal polyps, and other sinus-related conditions. While
nost patients have a positive experience with FESS, post-operative pair
is a common issue that can be difficult to manage. Opioids are routinely
used to manage post-operative pain but are associated with various side
effects, including nausea, vomiting, drowsiness, and respiratory
depression. Preventative analgesia is a pain management method that
reduces pain and opioid consumption following surgery. The use of
nalbuphine and dexmedetomidine for preventive analgesia in FESS has
been gaining increasing attention in recent years.FESS is mostly
performed under general anesthesia; post-operative pain management is
critical to patient care. Preventive analgesia is a technique that involves
administering analgesics before the onset of pain to prevent or reduce
the severity of post-operative pain. Two drugs commonly used for
preventive analgesia in FESS are nalbuphine and
dexmedetomidine.Nalbuphine is a synthetic opioid agonist-antagonist
that has been shown to provide adequate analgesia with a lower
incidence of side effects compared to other opioids. Nalbuphine acts on
mu and kappa opioid receptors to produce analgesia but also has
antagonist activity at the mu receptor, which reduces the risk of
respiratory depression and opioid-induced hyperalgesia
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist that produces sedation, analgesia, and anxiolysis. Dexmedetomidine has
been shown to reduce post-operative pain and opioid consumption in
various surgical procedures.Nalbuphine is an opioid agonist-antagonist
with a mixed agonist and antagonist effect on the mu, kappa, and delta
opioid receptors. This leads to a lower risk of respiratory depression and
opioid-induced hyperalgesia.On the other hand, dexmedetomidine is a
selective alpha-2 adrenergic receptor agonist that provides sedative
analgesic, and anxiolytic effects without causing significant
hemodynamic consequences. These drugs have been used together in
several studies to assess their effectiveness in giving preventive
analgesia for FESS.Despite the increasing attention to using nalbuphine
and dexmedetomidine for preventive analgesia in FESS, there is still a
research gap in determining the optimal dosage and administration
technique for these medications. Additional research is necessary to
determine the most effective and safe preventive analgesia strategy for
reducing post-operative pain and opioid consumption in FESS patients.
 
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