| 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
|
|
|
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
|
|
|
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?. |