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CTRI Number  CTRI/2020/12/029853 [Registered on: 16/12/2020] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Compare inhalational agent sevoflurane versus betablocker for controlling heart rate and blood pressure response to surgical stress in laparoscopic surgery  
Scientific Title of Study   Comparison between sevoflurane bolus and esmolol bolus for attenuating hemodynamic response to pneumoperitoneum in laparoscopic surgery- A prospective randomised study. 
Trial Acronym  SEVOBOLUS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NITA DSOUZA 
Designation  Consultant Anesthesiology 
Affiliation  Ruby hall clinic, pune 
Address  DEPARTMENT OF ANAESTHESIA 7TH FLOOR CANCER BUILDING RUBY HALL CLINIC 40 SASSOON ROAD CAMP PUNE 411001

Pune
MAHARASHTRA
411001
India 
Phone  09823721982  
Fax    
Email  drnita610@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  NITA DSOUZA 
Designation  Consultant Anesthesiology 
Affiliation  Ruby hall clinic, pune 
Address  DEPARTMENT OF ANAESTHESIA 7TH FLOOR CANCER BUILDING RUBY HALL CLINIC 40 SASSOON ROAD CAMP PUNE 411001

Pune
MAHARASHTRA
411001
India 
Phone  09823721982  
Fax    
Email  drnita610@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  SHEKH MOHIDEEN MAHEBUB 
Designation  ANAESTHESIA RESIDENT 
Affiliation  RUBY HALL CLINIC 
Address  DEPARTMENT OF ANAESTHESIA 7TH FLOOR CANCER BUILDING RUBY HALL CLINIC 40 SASSOON ROAD CAMP PUNE 411001
DEPARTMENT OF ANAESTHESIA 7TH FLOOR CANCER BUILDING RUBY HALL CLINIC 40 SASSOON ROAD CAMP PUNE 411001
Pune
MAHARASHTRA
411001
India 
Phone  8888268398  
Fax    
Email  mmshekh83@gmail.com  
 
Source of Monetary or Material Support  
RUBY HALL CLINIC PUNE MAHARASHTRA 
 
Primary Sponsor  
Name  Ruby Hall Clinic 
Address  DEPARTMENT OF ANAESTHESIA RUBY HALL CLINIC 40 SASSOON ROAD CAMP PUNE 411001 
Type of Sponsor  Private hospital/clinic 
 
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 
NITA DSOUZA  RUBY HALL CLINIC PUNE  DEPARTMENT OF ANAESTHESIA RUBY HALL CLINIC 40 SASSOON ROAD CAMP PUNE 411001
Pune
MAHARASHTRA 
9823721982

drnita610@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
POONA MEDICAL RESEARCH FOUNDATION  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  BOLUS DOSE OF SEVOFLURANE INHALATIONAL AGENT  After induction readings of HR,SBP,DBP,MAP ,inspiratory & expiratory sevoflurane will be taken. After appropriate positioning and before insertion of trocar and CO2 insuffulation ‘S’will receive 8% sevoflurane bolus of 6L/min for 2 minutes 
Comparator Agent  ESMOLOL beta blocker  Group ‘E’ will receive Esmolol 0.6mg/kg[21,22]. After 2 minutes of giving bolus dose in each group HR,SBP,DBP,MAP will be recorded every minute for 10 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • ASA PS I
• 18 - 60 years of age
• Male and Female
• Elective procedure under GA
• Mallampati airway class I &II
 
 
ExclusionCriteria 
Details  • Patient on beta-blockers
• Obese
• Difficult airway
• Severe Anaemia
• Allergic to drugs in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of Esmolol bolus and Sevoflurane bolus for controlling pressor response like heart rate,systolic BP,diastolic BP & Mean artereial pressure

 
Every minute for 10 minutes after the bolus of sevoflurane and esmolol in either group 
 
Secondary Outcome  
Outcome  TimePoints 
To determine any adverse effects in either group

To study time taken to control pressor response in either group
 
every minute hemodynamic parameters recorded for 10 minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   18/12/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 The pneumoperitoneum created using carbon dioxide (CO2) in laparoscopic surgery leads to stimulation of the sympathetic nervous system resulting in pathophysiological changes characterized by an increase in Heart rate, arterial pressure, systemic and pulmonary vascular resistance (SVR and PVR) immediately after the beginning of intra-abdominal insufflation.  It can be a risk factor for adverse cardiologic events in patients undergoing laparoscopic surgeries [1–4]. In addition, the anesthetic agents alter the cardiopulmonary function significantly [5].  Different pharmacological agents such as a2 adrenergic agonists, magnesium sulfate [6], beta-blockers [7], and opioids [8] are used to attenuate circulatory response due to pneumoperitoneum.

Esmolol, an ultra short-acting cardio-selective b1-receptor antagonist, has been shown to blunt hemodynamic responses to perioperative and intraoperative noxious stimuli due to overshooting sympathetic activity[9]. The heart rate and blood pressure-lowering effect start immediately after intravenous administration of esmolol and the effects are short-lasting as its elimination half-life is 9 minutes. Different doses of esmolol were used for attenuating surgical response such as ranging from 0.3mg/kg -1.5 mg/kg but doses ranging from 0.5-0.6mg/kg were found safe and effective.[10]

A general anesthetic must provide adequate hypnosis and analgesia as well as block motor and sympathetic responses which can be achieved by volatile anesthetics, local anesthetics acting on peripheral nerves, or an opioid acting on the spinal cord, midbrain, thalamus, and higher centers [11]. Moreover, the ideal anesthetic should suppress the hemodynamic responses to surgery without causing significant cardiovascular depression [12].

 An inhalation bolus minimizes this hysteresis through optimal use of the anesthesia apparatus, vaporizer setting, and fresh gas flow. To reach the desired anesthetic concentration without affecting normocapnia, the anesthesiologist may increase the inspired drug concentration, and if working with a closed circuit, the fresh gas may also be increased. There is usually a delay between a change in the vaporizer setting and the onset/offset of the desired clinical effect [13]. Low blood/gas solubility, absence of airway irritation, ease of titration, and cardiovascular stability make sevoflurane suitable for use when considering an inhalation bolus [14,15]. 

 Hypothetical question: Whether Sevoflurane when given as a bolus dose is comparable to a bolus dose of esmolol in controlling hemodynamic response to surgical stress (pneumoperitoneum) in laparoscopic surgery?.

 

 
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