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CTRI Number  CTRI/2021/07/034890 [Registered on: 15/07/2021] Trial Registered Prospectively
Last Modified On: 16/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Study Haemodynamic Effects Of Preoperative Single Bolus Of Dexmedetomidine In Elective Laparoscopic Surgeries 
Scientific Title of Study   Study Of Haemodynamic Effect Of Preoperative Single Bolus Of Dexmedetomidine In Elective Laparoscopic Surgeries 
Trial Acronym  Lap Dex 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Fathima 
Designation  Junior Resident 
Affiliation  Dr D Y Patil Medical College Hospital and Research Centre 
Address  Department of anesthesia Dr DY Patil Medical College and Research Centre
Department of anesthesia Dr DY Patil Medical College and Research Centre
Pune
MAHARASHTRA
411019
India 
Phone  09746290791  
Fax    
Email  drfthma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Girish Saundattikar 
Designation  Professor 
Affiliation  Dr D Y Patil Medical College Hospital and Research Centre 
Address  Department of anesthesia Dr DY Patil Medical College and Research Centre
Department of anesthesia Dr DY Patil Medical College and Research Centre
Pune
MAHARASHTRA
411019
India 
Phone  9096410540  
Fax    
Email  Fthm_93@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Mary Samuel 
Designation  Professor 
Affiliation  Dr D Y Patil Medical College Hospital and Research Centre 
Address  Department of anesthesia Dr DY Patil Medical College and Research Centre
Department of anesthesia Dr DY Patil Medical College and Research Centre
Pune
MAHARASHTRA
411019
India 
Phone  09746290791  
Fax    
Email  drfthma@gmail.com  
 
Source of Monetary or Material Support  
Central Pharmacy, DY Patil Medical College 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  Dr DY Patil Medical College and Research Centre 
Type of Sponsor  Research institution and hospital 
 
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 
Fathima  Operation Theatre  Dr. D. Y. Patil Medical College, Hospital & Research Centre, Sant Tukaram Nagar, Pimpri, Pune 411018 Maharashtra, India.
Pune
MAHARASHTRA 		 9746290791

drfthma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics sub committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% Normal Saline  50ml of 0.9% Normal Saline over 10 mins 
Comparator Agent  Dexmedetomidine  1 mcg / kg bolus in 50ml of 0.9% NS over 10 mins 
Intervention  General Anaesthesia in Laparoscopic surgeries  GENERAL ANAESTHESIA TECHNIQUE All the patients will be kept nil per oral (NPO) for a period of atleast 6hrs prior to surgery to avoid the risk of aspiration and other anaesthesia related complications. All patients will be thouroughly investigated and will be explained about the procedure. On the day of surgery, anaesthesia and resuscitation equipment will be checked and kept ready. On arrival of patient into operating room, ECG, NIBP, Pulse Oximetry will be attached and a base vital signs (HR, MAP, SpO2) will be recorded, I/V line will be secured on left forearm with 18G venflon and preloading done with 5ml/kg of crystalloids. INDUCTION OF GENERAL ANAESTHESIA Before induction patients in group D will receive I.V Dexmedetomidine at 1μgm/kg in 50 ml of 0.9% NS, and group S will receive 50 ml of 0.9% NS. A balanced general anaesthesia technique will be adopted for all patients, Premedication will be done with Inj. Glycopyrrolate 0.2mg, Inj Fentanyl 2μgm/kg, given intravenously. All patients will be pre-oxygenated with 100% of O2 by mask for 3 minutes. Induction with Inj. Propofol (2mg/kg) given slowly till the patient is induced and the vital parameters will be recorded again. The intubation will be facilitated by intravenous administration of injection succinyl choline 100mg. 12 The choice of muscle relaxant will be inj Vecuronium. Oxygen and Nitrous oxide will be continued (50% each) along with isoflurane (0.8-1%). The vital parameters will be recorded again. Laryngoscopy and tracheal intubation will be attempted by the same trained and qualified anaesthesiologist followed by recording of the vital parameters. Once the tracheal intubation has been achieved, the surgery will be allowed to proceed after fixing the endotracheal tube and confirming the bilateral air entry and giving positive pressure ventilation. Pneumoperitoneum created by intra peritoneal CO2 insufflation @ 2Ltrs/min and intra-abdominal pressure (IAP) maintained between 10-14mmHg through out surgery. Monitoring of parameters, i.e., heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) will be noted  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I and II
patients undergoing elective laparoscopic surgeries under general anaesthesia
Haemodynamically stable patietns
availability of informed consents 
 
ExclusionCriteria 
Details  Patient refusal
ASA III and more
age below 18 and above 60
patients posted for emergency surgeries
patients who are on drugs that can influence haemodynamic and autonomic functions
predictable difficult airway or difficult intubation
pre existing heart condition
pregnancy and breast feeing women
co-existing illness like respiratory, renal or cerebral diseases
surgeries converted to open surgeries
known allregy to any of the drugs used in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to study the effects of dexmedetomidine on hemodynamic parameters during perioperative periods in patients undergoing elective laparoscopic surgeries  Every 5 minutes post induction 
 
Secondary Outcome  
Outcome  TimePoints 
to study post operative sedation score using ramsay sedation scale  6 hours 
To study the time taken for the first analgesic requirement.  12 hours 
To study the side effects of Dexmedetomidine and their management  Every 5 minutes post induction
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   16/07/2021 
Date of Study Completion (India) 30/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drfthma@gmail.com].

  6. For how long will this data be available start date provided 01-03-2022 and end date provided 31-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Before induction patients will recieve IV Dexmedetomifine at 1 micrograms/ kg in 50 ml of 0.9% NS or 50 ml of  0.9% NS, and a balanced general anaesthesia technique will be adopted for all patients. Haemodynamic parameters will be assessed before the start of infusion, 10 mins after the start of infusion, immediately after induction, after laryngoscopy, intubation at 1, 3, 5 mins. Data will be collected from the time of pneumoperitoneum, after extubation. Postop pain score will be assessed and the time to first rescue analgesic requirement and total amount of analgesic drugs required during first 24 hours post operatively will be noted down. 
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