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CTRI Number  CTRI/2024/07/070958 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 21/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effectiveness of drugs in hemodynamic changes during laryngoscopy and intubation in patients undergoing surgey under General Anaesthesia. 
Scientific Title of Study   To compare the efficacy of oral Melatonin, Gabapentine, Clonidine and Placebo in attenuating hemodynamic response during laryngoscopy and intubation in patients undergoing surgery under General Anaesthesia , A four armed Randomized Double blinded clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpa Masur 
Designation  Associate professor ,Department of Anaesthesia 
Affiliation  Department of Anaesthesia ,S.Nijalingappa Medical College and HSK hospital ,Bagalkot 587102 
Address  Department of Anaesthesia S ,Nijalingappa Medical College and HSK hospital Bagalakot,Karnataka,India 587102 Bagalkot KARNATAKA India

Bagalkot
KARNATAKA
587102
India 
Phone  9844117959  
Fax    
Email  shilpamasur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Biradar 
Designation  Junior Resident Department of Anaesthesia  
Affiliation  Department of Anaesthesia ,S.Nijalingappa Medical College and HSK hospital ,Bagalkot 587102 
Address  JR Department of Anaesthesia S Nijalingappa Medical College and HSK Hospital,Bagalakot, Karnataka India 587102

Bagalkot
KARNATAKA
587102
India 
Phone  9844117959  
Fax    
Email  rashmibiradar28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shilpa Masur 
Designation  Associate professor ,Department of Anaesthesia 
Affiliation  Department of Anaesthesia ,S.Nijalingappa Medical College and HSK hospital ,Bagalkot 587102 
Address  Department of Anaesthesia S,Nijalingappa Medical College and HSK hospital,Bagalkot,Karnataka ,India 587102

Bagalkot
KARNATAKA
587102
India 
Phone  9844117959  
Fax    
Email  shilpamasur@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,S.Nijalingappa Medical College and HSK hospital ,Bagalakote 587102 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  Department of Anaesthesia S.Nijalingappa Medical College and HSK Hospital Bagalakot ,587102 Karnataka ,India  
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 
Dr Shilpa Masur  S. Nijalingappa Medical College and HSK Hospital Navanagar Bagalakote  Department of Anaesthesia ,Major Ot Complex
Bagalkot
KARNATAKA 		 9844117959

shilpamasur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S.Nijalingappa Medical College and HSK Hospital ,Bagalkot 587102  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 
Intervention  NIL  NIL 
Comparator Agent  Patients undergoing Surgeries under General Aaesthesia   Drug – Placebo Variables Heart Rate BP Before administration of drug Before Pre medication After Pre medication During Laryngoscopy and Intubation Post 1 min Post 2 min Post 3 min Post 4 min After extubation (Post 10 min)  
Comparator Agent  Patients undergoing surgeries under General Anaesthesia   Drug -Clonidine Variables Heart Rate BP Before administration of drug Before Pre medication After Pre medication During Laryngoscopy and Intubation Post 1 min Post 2 min Post 3min Post 4min After extubation ( Post 10 min)  
Comparator Agent  Patients undergoing Surgeries under General Anaesthesia   Drug – Gabapentin Variables Heart Rate BP Before administration of drug Before Pre medication After Pre medication During Laryngoscopy and Intubation Post 1min Post 2 min Post 3 min Post 4min After extubation ( Post 10 min)  
Comparator Agent  Patients undergoing surgeries under General Anesthesia.  • After obtaining written informed consent, the patients will be divided into four groups (20 patients each) with computer generated table of random numbers in opaque sealed envelops. • All patients will be subjected to routine pre-anesthetic checkup in the preoperative period. All routine investigations as appropriate for the surgeries will be obtained and optimised. • Group M will receive oral melatonin 6mg, Group C will receive oral clonidine100mcg,Group G 100mg gabapentin, Group P a multivitamin tablet 120 minutes prior to surgery with sips of water. Tablets will be removed from envelope by other post graduate student and handed over to anesthesiologist for administration to the patient. • The post graduate student will not be involved in the trial. Two anesthesiologists will be involved in the study—one will administer the drug while the other will conduct the case and record the data. During the study following parameters will be estimated: Drug – Melatonin Variables Heart Rate BP Before administration of drug Before Pre medication After Pre medication During Laryngoscopy and Intubation first 1 min Post 2min Post 3 min Post 4min After extubation ( Post 10 min)  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients within ASA Grade 1 and 2
2 Patients in the age of 20-60 yrs
3 Elective surgeries under GA with endotracheal intubation 
 
ExclusionCriteria 
Details  1 Patients with anticipated difficult airway
2 Pregnant patients
3 Patients on antipsychotics ,sedatives ,anxiolytics and antiepileptics
4 Patients refusal to give consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of hemodynamic changes during laryngoscopy and intubation and after extubation  During laryngoscopy and intubation first 1 min ,2nd min ,3rd min ,4th min and post extubation 10 min 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the requirement of injection propofol for Propofol for induction and requirement of isoflurane during intraoperative period  Till surgery get over 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/08/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

•        After obtaining written informed consent, the patients will be divided into four groups (20 patients each) with computer generated table of random numbers in opaque sealed envelops.

•        All patients will be subjected to routine pre-anesthetic checkup in the preoperative period. All routine investigations as appropriate for the surgeries will be obtained and optimised.

•        Group M will receive oral melatonin 6mg, Group C will receive oral clonidine100mcg,Group G 100mg gabapentin, Group P a multivitamin tablet 120 minutes prior to surgery with sips of water. Tablets will be removed from envelope by other  post graduate student and handed over to anesthesiologist for administration to the patient.

•        The post graduate student will not be involved in the trial.  Two anesthesiologists will be  involved in the study—one will administer the drug while the other will conduct the case and record the data.

•        All patients will be kept undisturbed, wear black blindfolds and the rooms will be kept calm and silent. Patients will be shifted to the operation theater ten minutes prior to surgery.

•        To ensure double blinding, both the anesthesiologists and the patients will be kept unaware of group allocation.

•        Before shifting patient to oT baseline heart rate and blood pressure will be recorded.

•      In the operating room, standard monitoring (heart rate, non-invasive measurement of systolic, diastolic and mean blood pressure oxygen saturation, electrocardiography) will be applied, and recorded.

•        Intravenous line will be secured with 18 G cannula and infusion of injection Ringer Lactate commenced at the rate of 10 ml/kg/hr.•        After three minutes of pre-oxygenation with 100% oxygen, inj.Emeset 0.15mg/kg,

•        Inj.glycopyrrolate 0.01mg/kg , inj.fentanyl 2 μg/kg will be administered to all patients.

•        Patients will be induced with Inj.propofol 2mg/kg given slowly over 1 minute till there was loss of response to verbal commands ,loss of eye lash reflex or transient apnea .With this dose of propofol required for induction will be determined.

•        After ensuring mask ventilation all patients will be given  Inj. vecuronium 0.1 mg/kg intravenously to facilitate endotracheal intubation.

       Anesthesia will be maintained with isoflurane 1%–1.5% in oxygen Nâ‚‚O mixture (1:1), initially with mechanical ventilation with tidal volume of 6–8 mL/kg, respiratory rate of 12–

•        14 per minute maintaining end�’tidal carbon dioxide (EtCO2) between 30 and 35 mmHg and to maintain HR and BP within 20% of the baseline values.

•      Heart rate (HR) and mean arterial pressures (MAPs) will be recorded before premedication, before induction of anesthesia, immediately after induction and then at 1,2,3,4,5and 10 minutes after intubation.

•    An increase in HR >20% from baseline, if associated with hypotension, will be treated with 250mL intravenous Ringer’s lactate bolus initially. If increase in HR did not respond or was associated with increase in MAP >20% from baseline, isoflurane concentration will be increased to 1.5%–2%.

•        If the hemodynamic response would not controlled, incremental boluses of fentanyl 0.5 μg/kg will be given to a maximum of 1 μg/kg in one hour.

•        Reduction in MAP <20% from baseline value was taken as hypotension and will be treated with 250 mL intravenous fluid bolus; if not responding, incremental doses of phenylephrine 50 μg will be given.

•        Isoflurane concentration will be reduced to 0.5% at beginning of skin suturing and discontinued at completion of suturing.

•        Total duration of the surgery and  average percentage of the dial setting on the Tec 7 vaporizer will be noted. Total amount of the isoflurane required is calculated using the formula

EISENKRAFT FORMULA:-

CONSUMPTION=3×FGF×Set concentration.

•        Neuromuscular blockade will then reversed and extubation will be done when patient will be opening eyes on command and generating adequate tidal volume with return of protective airway reflexes.

 

Expected duration of the subject participation: 24 hours


 
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