INTRANASAL DEXMEDETOMIDINE FOR POSTOPERATIVE ANALGESIA IN GERIATRIC PATIENTS
Scientific Title of Study
INTRANASAL DEXMEDETOMIDINE FOR POSTOPERATIVE ANALGESIA IN GERIATRIC PATIENTS UNDER GOING LOWER LIMB ORTHOPEDIC SURGERIES
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
UDUMULA ANUDEEPIKA REDDY
Designation
ANAESTHESIA RESIDENT IN POST GRADUATION
Affiliation
SHRI B.M. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE
Address
SHRI B.M. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE,BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD, VIJAYAPURA,KARNATAKA,586103
Bijapur KARNATAKA 586103 India
Phone
8431192603
Fax
Email
ANUDEEPIKAREDDYUDUMULA@GMAIL.COM
Details of Contact Person Scientific Query
Name
Renuka S Biradar
Designation
Professor and HOD In Anaesthesia
Affiliation
Shri B.M. Patil Medical college, hospital and research centre HOSPITAL AND RESEARCH CENTRE
Address
Shri B.M.Patil Medical College Hospital and research centre,Bangaramma Sajjan campus, Solapur Road, Vijayapura, Karanataka, 586103
Bijapur KARNATAKA 586103 India
Phone
9886492178
Fax
Email
renuka312@gmail.com
Details of Contact Person Public Query
Name
Dr. U.Anudeepika Reddy
Designation
Junior Resident
Affiliation
Shri B.M. Patil Medical college, hospital and research centre HOSPITAL AND RESEARCH CENTRE
Address
Shri B.M. patil Medical College, Hospital and research centre, Bangaramma Sajjan campus,Solapur Road Vijayapura karanataka,586103
Bijapur KARNATAKA 586103 India
Phone
9121893620
Fax
Email
anudeepikareddy96@gmail.com
Source of Monetary or Material Support
SHRI B.M. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE
Primary Sponsor
Name
DrU Anudeepika Reddy
Address
Shri B.M.Patil medical college, hospital and research centre, solapur Road,Vijayapura, karanataka,586103
Type of Sponsor
Other [SELF]
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
Anudeepikareddy
SHRI B M PATIL MEDICAL COLLEGE AND RESEARCH CENTRE VIJAYAPURA
Room number 206
Post anaesthetic care unit Bijapur KARNATAKA
8431192604
anudeepikareddy96@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
BLDE(DEEMED To be university) institutional ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: O||Medical and Surgical,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Patient allocated in C group are administered with Intranasal Normal saline
After shifting geriatric patients who underwent lower limb Orthopedic Surgeries to PACU when patient complained of pain Intranasal Normal saline of 1ml; 0.5 ml in each nostril is administered through nasal atomiser in semirecumbent position as analgesia and vitals, vas score, mrass score are measured after 15min 30min 45min,1 Hour, 2 hours,4 hours 6 hours ,12 hours and 24 hours.These parameters are compared with D group parameters
Intervention
Patient allocated in D group are administered with Intranasal Dexmedetomidine
After shifting geriatric patients who underwent lower limb Orthopedic Surgeries to PACU;when patient complained of pain 0.6 microgram/kg of 1ml Intranasal Dexmedetomidine is administered 0.5 ml in each nostril through nasal atomiser in semirecumbent position as analgesia and vitals,vas score,mrass score are measured after 15 min,30 min,45 min,1 hour,2 hours,4 hours,6 hours,12 hours and 24 hours
Inclusion Criteria
Age From
65.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
Patients aged 65 years and above, Patients undergoing lower limb orthopaedic surgeries subarachnoid blockade, Patients with ASA grading 1,2
ExclusionCriteria
Details
Known hypersensitivity or allergy to dexmedetomidine , Patients receiving antidepressants, Contraindication for nasal drug administration ,nasal trauma or obstruction such a copious mucous, bleeding, anatomic, tumoral or foreign body obstruction ,Documented risk of respiratory distress recent within 7 days need to be ventilated, recent respiratory impairment with an increased degree of dyspnea or a recent tachypnea more than 20 mins, known sleep apnea without non-invasive, ventilation support, Documented cardiac risk ,congestive heart failure, known life-threatening heart rhythm or conduction disorders, bradycardia less than 60 bpm or atrioventricular block without pacemaker, systolic blood pressure less than 100 mmHg, digoxin treatment ,Recent stroke less than 1 month, Patients currently on beta blocker
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The objective is to study the efficacy of intranasal dexmedetomidine as postoperative analgesia in geriatrics patients after lower limb orthopedic surgeries,To study the VAS scores in the 24 hr post op period, To study the analgesic consumption in the 24 hr post op period.
Total Sample Size="100" Sample Size from India="100" 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)
16/10/2025
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="0" 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
All patients will undergo a pre anaesthetic evaluation to ensure safe anaesthetic planning and perioperative care. This will include a detailed history of chronic illnesses such as hypertension, diabetes, asthma, and cardiac conditions, along with prior surgeries, previous anaesthetic exposure, hospital admissions, and any known drug allergies. A complete physical examination will be conducted to assess the patient’s general condition. Baseline vital parameters including heart rate, blood pressure, respiratory rate, mean arterial pressure, and body mass index will be recorded. Systemic examinations of the respiratory, cardiovascular, central nervous, and vertebral systems will be performed. Airway assessment will include Mallampati grading, mouth opening, neck mobility, dentition, and thyromental distance.
Subarachnoid block will be administered using three millilitres of zero point five percent hyperbaric bupivacaine under strict aseptic precautions. Intraoperatively, heart rate, non invasive blood pressure, mean arterial pressure, oxygen saturation, and respiratory rate will be continuously monitored. Postoperatively, patients will be observed in the post anaesthesia care unit until recovery, and vitals will be recorded. Pain will be assessed using the Visual Analogue Scale ranging from zero to ten. If the Visual Analogue Scale score exceeds four, intravenous paracetamol fifteen milligrams per kilogram will be administered. Patients will be randomized into two groups, D and C. Both groups will receive intranasal medication using a mucosal atomizer. The D group will receive dexmedetomidine zero point six micrograms per kilogram which is one millilitre, while the C group will receive one millilitre of normal saline. The study will be conducted in a double blinded manner. Parameters such as heart rate, respiratory rate, non invasive blood pressure, mean arterial pressure, oxygen saturation, and Visual Analogue Scale will be recorded at baseline, fifteen minutes, thirty minutes, forty five minutes, one hour, two hours, four hours, six hours, twelve hours, and twenty four hours. Sedation will be assessed every two hours using the modified Richmond Agitation Sedation Scale which ranges from plus four, which is combative, to minus five, which is unarousable, with zero indicating alert and calm. This study design allows a safe evaluation of intranasal dexmedetomidine for postoperative sedation and analgesia.