Comparison of effectiveness of steroid v/s trial drug given by inhalation before surgery to suppress sore throat that is seen after general anaesthesia
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/01/049232
- Lead Sponsor
- Dr Nadashree A S
- Brief Summary
A prospective, randomised comparative study titled “COMPARISON OF
EFFECTIVENESS OF NEBULIZED DEXAMETHASONE V/S NEBULIZED
DEXMEDETOMIDINE IN PREVENTION OF POST OPERATIVE SORE
THROAT AFTER GENERAL ENDOTRACHEAL ANAESTHESIA” was
conducted at McGann Teaching District Hospital attached to Shimoga Institute of
Medical Sciences, Shivamogga from October 2022 to March 2024.The study was
conducted on 100 subjects undergoing elective surgeries requiring general anaesthesia
with endotracheal intubation technique, after obtaining clearance from Institutional
Ethical Committee and Informed Consent was taken from all the subjects involved in
the study.
100 patients scheduled for various elective surgical procedures belonging to
ASA physical status 1 and 2; age group of 18-60 years were included in the present
study. Patients with pre operative sore throat or cold ;undergoing intraoral surgeries;
patients with Asthma/COPD; known allergies to study drug ;Pregnant patients
;Anticipated difficult airway were excluded from the study.
The patients were randomly allocated into two groups of 50 each:
Group 1- received nebulization of 8mg(2ml) of Dexamethasone diluted to 5ml
using Normal saline.
Group 2- received nebulization of 50 microgram(0.5ml) of Dexmedetomidine
diluted to 5ml using Normal saline.Pre-anaesthetic evaluation was done on the previous day and informed consent
was obtained. IV line was secured. The study drug was given by nebulization for 15
minutes in the preoperative room.Pre nebulization and post nebulization hemodynamic
parameters were noted. Patients were shifted to operating room. ASA standard monitors
(ECG,Pulse oximeter, NIBP, Temperature and end tidal CO2 ) were attached. 15
minutes after the completion of nebulization, General anaesthesia was provided.
Premedication with injection midazolam 0.02mg/kg, injection fentanyl 2 microgram/kg
and induction with injection propofol 2mg/kg after preoxygenation with 100 % O2 for
3 minutes through face mask was done. Tracheal intubation was facilitated with
injection vecuronium 0.1mg/kg IV. All patients were intubated with sterile cuffed
polyvinyl chloride tubes of appropriate size. The tracheal cuff was then inflated with
air to cuff pressure of 20cm H2O and thereafter cuff pressure was checked every 15
minutes to maintain the same pressure till the end of surgery.
After confirmation of tracheal tube position anaesthesia was maintained with
O2, N2O, isoflurane and intermittent doses of vecuronium and ventilated using IPPV.
Injection ondansetron 4mg IV was given 30 minutes before the end of the procedure.
At the end of the surgery gentle suctioning of oropharynx was done. Then inspiratory
O2 concentration was kept at 100%. The residual neuromuscular block was reversed
with 50microgram /kg of neostigmine and 10microgram/kg glycopyrrolate and patient
was extubated.
After extubation, patient was shifted to recovery room where patients was
assessed for sore throat at 0th hour, then at 2nd, 6th, 12th, 24th hr in post operative ward
and graded on 4 point scale (0-3).The hemodynamic parameters such as HR,SBP,DBP and MAP were recorded
before nebulisation, after nebulisation,before intubation, immediately after intubation-
0
th minute, 2nd minute and 5th minute post-intubation.
There was no significant statistical difference at 0th, 2nd, 12th, 24th hour in terms
of incidence and severity of postoperative sore throat.
There was statistically significant fall in heart rate in Dexmedetomidine group
compared to Dexamethasone group after nebulisation during all time intervals in the
study period except second minute after intubation.
There was statistically significant fall in systolic blood pressure and mean
arterial pressure , 2nd minute after intubation in Dexmedetomidine group compared to
Dexamethasone group.
There was no statistically significant difference with respect to diastolic blood
pressure in both the groups at all time intervals in the study period.
Hence, Dexmedetomidine 50mcg given as nebulization preoperatively 15
minutes before induction of anaesthesia is as effective as nebulized Dexamethasone
8mg in prevention of post operative sore throat without any significant bradycardia and
hypotension. Nebulized dexmedetomidine also has an added advantage of attenuation
of haemodynamic stress response to laryngoscopy and endotracheal intubation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- 1.Age between 18-65 years of either sex belonging to ASA-I-II.
- 2.Elective surgery in supine position requiring general anaesthesia with endotracheal intubation.
1.Pre operative sore throat or cold 2.Intraoral surgeries 3.Asthma, COPD 4.Known allergies to study drug 5.Pregnant patients 6.Anticipated difficult airway.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of post operative sore throat graded on 4 point scale (0-3) At 0th hour and then at 2nd, 6th, 12th, 24th hour 0-No sore throat At 0th hour and then at 2nd, 6th, 12th, 24th hour 1-Mild sore throat(upon asking only patient complaints of sore throat) At 0th hour and then at 2nd, 6th, 12th, 24th hour 2-Moderate sore throat (patient himself complaints of sore throat) At 0th hour and then at 2nd, 6th, 12th, 24th hour 3-Severe sore throat (change of voice or hoarseness associated with throat pain) At 0th hour and then at 2nd, 6th, 12th, 24th hour
- Secondary Outcome Measures
Name Time Method Attenuation of hemodynamic stress response to laryngoscope and intubation 5 minutes
Trial Locations
- Locations (1)
McGann Hospital
🇮🇳Shimoga, KARNATAKA, India
McGann Hospital🇮🇳Shimoga, KARNATAKA, IndiaDr Nadashree A SPrincipal investigator09945816544asnadashree@gmail.com