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CTRI Number  CTRI/2020/12/029517 [Registered on: 03/12/2020] Trial Registered Prospectively
Last Modified On: 13/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of dexmedetomidine used during surgery for smooth recovery from general anaesthesia in laparoscopic surgeries. 
Scientific Title of Study   Efficacy of continuous peri-operative infusion of dexmedetomidine for smooth emergence from general anaesthesia in laparoscopic surgeries.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemlata Kamat 
Designation  Professor  
Affiliation  H.M.Patel center for medical care and Education 
Address  Department of Anaesthesiology, Shree Krishna hospital and Pramukh swami Medical College,Anand-Sojitra road, Karamsad

Anand
GUJARAT
380325
India 
Phone  9375031313  
Fax    
Email  hemlatavk@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemlata Kamat 
Designation  Professor  
Affiliation  H.M.Patel center for medical care and Education 
Address  Department of Anaesthesiology, Shree Krishna hospital and Pramukh swami Medical College,Anand-Sojitra road, Karamsad

Anand
GUJARAT
380325
India 
Phone  9375031313  
Fax    
Email  hemlatavk@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr Kulin Shrimali  
Designation  Resident Doctor  
Affiliation  H.M.Patel center for medical care and education 
Address  Department of Anaesthesia,Pramukh swami Medical College,Shree Krishna hospital, Gokalnagar, Anand-Sojitra raoad,Karamsad, Anand

Anand
GUJARAT
380325
India 
Phone  7575848969  
Fax    
Email  kulin.shrimali@gmail.com  
 
Source of Monetary or Material Support  
Shree Krishna hospital, Anand-Sojitra road,Karamsad,Anand. 388325 
 
Primary Sponsor  
Name  Shree Krishna hospital  
Address  Gokalnagar,Anand-Sojitra road,Karamsad, Anand, 388325 
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 Hemlata Kamat   Shree Krishna hospital   Surgery and Gynec operation theaters, 1st floor , Shree Krishna hospital ,Gokalnagar,Anand-Sojitra road,Karamsad.388325
Anand
GUJARAT 
9909929422

hemlatavk@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H.M.Patel center for medical care and education   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: R688||Other general symptoms and signs, (3) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continuous intravenous dexmedetomidine infusion   Inj Dexmedetomidine loading dose of 1 mcg/kg over 15 minutes;(20 minutes before the start of surgery) followed by continuous intravenous dexmedetomidine infusion at the rate of 0.4 mcg/kg will be given in control group till pnuemoperitoneum will be deflated by surgeon. 
Intervention  Continuous Intravenous dexmedetomidine infusion  Inj Dexmedetomidine loading dose of 1 mcg/kg over 15 minutes;(20 minutes before the start of surgery) followed by continuous intravenous dexmedetomidine infusion at the rate of 0.4 mcg/kg will be given in study group till the time of administration of neostigmine (reversal agent). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with ASA grade 1,2,3 physical status undergoing elective laparoscopic surgeries under general anaesthesia with estimated time of 1-3 hours.  
 
ExclusionCriteria 
Details  1)Known allergy for dexmedetomidine
2)Obese(BMI >35kg/m2)
3)Febrile
4)Pregnant females
5)Patients who is on antidepressants or opioid or non-opioid analgesics.
6)Pulse rate <60min 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To observe the effect of IV dexmedetomidine on quality of emergence from general anaesthesia in terms of cough suppression and agitation.  Post surgery at every 5 minutes( 0min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min) 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the effect of IV dexmedetomidine on quality of emergence from general anaesthesia in terms of shivering and heamodynamics and time to extubation.  Post surgery at every 5 minutes( 0min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min).
Time to Extubation measured from switching off sevoflourane to removal of endotracheal tube. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/12/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
After Obtaining ethical committee approval and patient’s written and informed consent, patients of ASA I/II/III physical status who will be undergoing elective laparoscopic surgery under general anaesthesia with estimated time of 1-3 hours will be recruited to participate in randomized controlled trial. The participant would be randomly allocated to group C or group D by computer generated random numbers. Results of randomization will be kept in concealed opaque envelopes and opened sequentially immediately before study drug administration. Routine monitors will be applied including BP cuff, electrocardiogram leads, Pulse oximeter probe, capnometry , esophageal temperature probe , peripheral nerve stimulator using Train of four(TOF) throughout the surgery. In all patients Inj dexmedetomidine loading dose (1µg/kg) over 15mins will be given followed by an infusion, at the rate of 0.4µg/kg/hr started 20mins prior to induction. Anaesthesia will be induced using IV Glycopyrrolate 0.04mg/kg mg, IV fentanyl 2 µg/kg, IV xylocard 1.5 mg/kg, IV Propofol and 1.5-2 mg/kg, Vecuronium 0.1 mg/kg or scoline 2mg/kg depending on the airway management. After orotracheal intubation and Ryles tube insertion, anaesthesia will be maintained using O2+air, sevoflurane 1%-3% , using low flows (1-2 lits) in close circuit and volume controlled ventilation with tidal volume 7ml/kg and respiratory rate of 10-14 in order to maintain the ETCO2 around 30mmHg with FIO2 of 50%. Intermittent doses of Inj fentanyl will be given every hourly to keep the blood pressure and heart rate within 20% of baseline and Inj. vecuronium will be titrated according to TOF monitoring i.e. will be repeated on appearance of three twitches. In control group, when pneumoperitoneum will be deflated by surgeon, dexmedetomidine infusion will be stopped. In experimental group D, dexmedetomidine infusion will be continued till the time of administration of neostigmine(reversal agent), when all four twitches of equal amplitude will be obtained on TOF stimulation. In all patients, at the end of surgery (skin suturing completed), Sevoflurane will be stopped (Defined as time zero or baseline of emergence process), fresh gas flow will be increased to 4-6lit/min, and Ondansetron 4 mg IV will be given and Orogasric suction will be performed. From Time zero till 15 minutes post extubation, systolic BP, Diastolic BP , heart rate, Spo2 and end tidal CO2, Agitation, Cough Scores and no. of coughing episodes will be recorded every 5 minutes. Patient will be reversed with Inj neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg,.Trachea will be extubated when patient will be awake, spontaneous eye opening and reflexes present. The following will be recorded: total duration of anaesthesia and duration of surgery and time to extubation. Time to Extubation is defined as Time from switching off the sevoflurane to removal of the endotracheal tube. Duration of surgery will be defined as time of skin incision to completion of skin suturing. Duration of anaesthesia will be defined as time from induction by propofol to reversal with inj neostigmine and glycopyrrolate.
 
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