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CTRI Number  CTRI/2024/07/069701 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 22/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Effects of Intravenous Dexmeditomidine bolus Versus intravenous Dexmeditomidine bolus with continuous intravenous injection of lignocaine on Measurements of blood pressure, heart rate, oxygen saturation in patients undergoing Short Laparoscopic Surgeries . 
Scientific Title of Study   Effects of Intravenous Dexmeditomidine Bolus Versus IV Dexmeditomidine Bolus with IV Lignocaine Infusion on Perioperative Hemodynamics in Patients Undergoing Short Laparoscopic Surgeries – A Randomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha M 
Designation  Post graduate student in Department of anaesthesiology 
Affiliation  Vijaynagar institute of medical sciences  
Address  Department of Anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9632551363  
Fax    
Email  megu.gwiz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Megha M 
Designation  Post graduate student in Department of anaesthesiology 
Affiliation  Vijaynagar institute of medical sciences  
Address  Department of Anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9632551363  
Fax    
Email  megu.gwiz@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anuradha H 
Designation  Associate professor, department of Anaesthesiology  
Affiliation  Vijaynagar institute of medical sciences  
Address  Department of Anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari.

Bellary
KARNATAKA
583104
India 
Phone  8095106846  
Fax    
Email  hanuradha19@yahoo.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Vijaynagar institute of medical sciences  
Address  Department of Anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari , Karnataka, India 583104 
Type of Sponsor  Government 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 Megha M  Vijaynagar institute of medical sciences  Department of anaesthesiology, major OT complex, Cantonment , Ballari
Bellary
KARNATAKA 
9632551363

megu.gwiz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , VIMS  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  Dexmeditomidine group as Group D  Inj. Dexmedetomidine 0.6 mcg/kg IV bolus diluted to 10ml given over 10 mins & normal saline 10ml bolus over 10mins given and normal saline infusion equivalent to study drug started before intubation with syringe pump.  
Intervention  Inj.Dexmeditomidine and inj. Lignocaine group as Group DL.  Inj. Dexmedetomidine 0.6 mcg/kg IV bolus diluted to 10ml given over 10 mins & inj. IV lignocaine bolus 1.5 mg/kg diluted to 10ml over 10min given and Inj. Lignocaine 1.5mg/kg/hr. infusion started before intubation with syringe pump.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients undergoing short laparoscopic surgeries and are ASA grade 1or2 
 
ExclusionCriteria 
Details  Refusal of patient for the clinical trial
Patient with history of severe hepatic, renal, cardiac and neurological disease, diabetes with autonomic dysfunction, uncontrolled hypertension, obesity body mass index more than 30kgperm2
Patient on chronic use of sedative medications
Allergy to local anesthetics like lignocaine
Inability to comprehend pain assessment 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in mean arterial pressure after 15 mins after pneumoperitoneum in short laparoscopic Surgeries.  Above parameters recorded At following intervals– on arrival into OT [basal value], after study drug bolus, pre
induction, post intubation at 1min, at every 5min and 15 mins till the initiation of
pneumoperitoneum insufflation, immediate post insufflation and every 15min till the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in systolic blood pressure (SBP) diastolic blood pressure (DBP) and heart rate
. Duration till post-operative rescue analgesia based on NRS pain scale [0-10]
.
Incidence of post-operative nausea vomiting by VDS scale [0-4]
.
Incidence of post operative shivering.
Quality of recovery after extubation by QoR40 scale 
Pain by NRS and duration for rescue analgesia , incidence & severity of PONV by VDS , aldrete score are measured at 5 mins, 15 mins and 30 mins followed by every hour till discharge from PACU. Quality of recovery assessed by QoR40 scale over next 24 hours
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/07/2024 
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="2"
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   This prospective study will be conducted on patients, aged between 20-40 years, belonging to
American Society of Anesthesiologists (ASA) Physical status I
and II, undergoing elective short laparoscopic surgeries under General anesthesia. After
obtainingthe informed written consent,
All patients included in the study will undergo thorough pre an aesthetic evaluation and
standard investigations as per ISA preoperative investigations guidelines. Patients will
be kept fasting as per ISA fasting guidelines 2019. On the day of surgery, patientswill be
shifted to operation theatre and basic routine monitors (ECG, NIBP and pulse
oximeter) are connected and baseline hemodynamic parameters -heart rate (HR), systolic blood
pressure (SBP), diastolic blood pressure (DBP) and mean blood arterial pressure (MABP)
recorded.
Randomization of study sample is done by simple randomization generated by using
www.randomization.com .Allocation concealment done by serially numbered opaque
envelope method (SNOSE technique). Study drugs are prepared by an anesthesia
resident not involved in the study. Administration of study drug and study observations
are done by another anesthesia resident blinded to the preparation of study drugs.
In the operating room, I V cannula will be secured, RL infusion will be started.
Inj. Glycopyrrolate 0.01mg/kg, inj. Midazolam 0.03mg/kg IV will be given.
Patients will be divided into 2 groups:
Group DL: Inj. Dexmedetomidine 0.6 mcg/kg IV bolus diluted to 10ml given over 10 mins &
inj. IV lignocaine bolus 1.5 mg/kg diluted to 10ml over 10min given and Inj. Lignocaine
1.5mg/kg/hr. infusion started before intubation with syringe pump.
Group D (Control Group): Inj. Dexmedetomidine 0.6 mcg/kg IV bolus diluted to 10ml given
over 10 mins & normal saline 10ml bolus over 10mins given and normal saline infusion
equivalent to study drug started before intubation with syringe pump.
Preoxygenation for 3min followed by IV Induction will be done with inj. Propofol
2mg/kg and in Vecuronium bromide 0.1mg/kg.
Endotracheal intubation will be done by appropriate endotracheal tube and correct
position is confirmed by 5-point chest auscultation and capnography.
Anesthesia is maintained with air (66%), oxygen (34%), isoflurane 0.6 and intermittent
bolus doses of vecuronium bromide 0.02 mg/kg to provide surgical relaxation. Patients
are connected to circuit system and minute ventilation is adjusted to maintain ETCO2 of
35-45mmhg.
Following the completion of surgery and deflation of pneumoperitoneum the infusion of
study drugs is stopped. At the time of skin closure, isoflurane will be discontinued.
Residual neuromuscular blockade will be reversed with inj. neostigmine (0.05mg/kg)
and inj. glycopyrrolate (0.01mg/kg) IV. When the signs of adequate reversal are met,extubation is performed and shifted to post anesthesia care unit [PACU] after
confirming stable vital parameters. Quality of recovery is assessed by QoR40 scale over next
24hrs.
Parameters observed:
Hemodynamic parameters- systolic blood pressure (SBP), diastolic blood pressure
(DBP), mean arterial pressure (MAP) and heart rate (HR) and are recorded
At following intervals– on arrival into OT [basal value], after study drug bolus, pre
induction, post intubation at 1min, at every 5min and 15 mins till the initiation of
pneumoperitoneum insufflation, immediate post insufflation and every 15min till the end of
surgery.
Intraabdominal pressures will be maintained at 12-15 mm Hg.
Patients will be observed for bradycardia (HR below 20% of baseline), hypotension
(MAP below 20% of baseline) during intra-operative period.
Brady cardia is treated with in Atropine 0.6mg and hypotension with inj. mephentermine
6mg IV. MAP and HR above 20% baseline will be treated with IV labetalol 10-20mg.
In PACU-
1.Severity of surgical site pain is assessed by Numerical rating scale [NRS 0 -10] and duration
is noted for rescue analgesia if NRS ≥ 4at rest.
2.The incidence and severity of PONV will be assessed in PACU in both the groups by
applying [0-4] point verbal descriptive scale [VDS][10]:
0- no complaint
1-mild degree of nausea
2-moderate degree of nausea
3- Frequent vomiting
4- severe vomiting (continuous vomiting)
If VDS >2 – INJ ONDANSETRON 4mgIV given. The incidence and severity will be
noted.
3. The patients are discharged from PACU after attaining modified Aldrete score [12]
of 9/10.
All the above parameters are assessed at 5min, 15min, and 30min
followed by every hour till discharge from PACU.
Quality of recovery is assessed by QoR40 scale over next 24hrs.
 Data management and statistics 
The data will be entered in MS excel sheet and the averages / means, proportions / percentages , gradings are noted.
The continuous variables related to intraoperative Mean arterial pressure, SBP, DBP , Heart rate, SpO2, ECG noted at After study drug bolus,Pre induction, Post Intubation,1min, 5min,15mins, Pneumoinsufflation, Immediate-Post insufflation ,5min,15min,
30min and expressed in their respective units.
Postoperative monitoring in PACU pain NRS score, PONV in VDS score, aldrete score are expressed.And the other data related to patient’s characteristics such as age, address , diagnosis, basal vitals & the vitals trend intraoperatively and other data related to patient will be entered as necessary. The data will be checked for uniformity of distribution.
 
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