| CTRI Number |
CTRI/2023/04/051448 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the effects of intravenous dexmedetomidine and magnesium sulphate given in addition to general anaesthesia on perioperative haemodynamics in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Evaluate and compare the effects of intravenous dexmedetomidine and
magnesium sulphate as adjunct to general anesthesia on perioperative haemodynamics
variability in patient undergoing laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Johar |
| Designation |
Professor |
| Affiliation |
Pt B. D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care , Pt. B. D. Sharma , PGIMS ,Rohtak
Rohtak
HARYANA
1224001
India |
| Phone |
9416050652 |
| Fax |
|
| Email |
sanjays321@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Gupta |
| Designation |
Junior Resident |
| Affiliation |
Pt B. D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care , Pt. B. D. Sharma , PGIMS ,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9643709289 |
| Fax |
|
| Email |
Vaishali.guptaa4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Gupta |
| Designation |
Junior Resident |
| Affiliation |
Pt B. D. Sharma , PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care , Pt. B. D. Sharma , PGIMS ,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9643709289 |
| Fax |
|
| Email |
Vaishali.guptaa4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, PtB. D. SharmaPGIMS ,Rohtak, Haryana |
|
|
Primary Sponsor
|
| Name |
Pt B. D. Sharma University Of Health Sciences, PGIMS,Rohtak, Haryana |
| Address |
Pt B. D. Sharma University Of Health Sciences, PGIMS,Rohtak, Haryana |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Vaishali Gupta |
Pt B. D. Sharma , PGIMS |
Department of anaesthesiology and Critical care , PGIMS, Rohtak
Rohtak
HARYANA |
9643709289
Vaishali.guptaa4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt B. D. Sharma PGIMS Rohtak |
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 |
| Comparator Agent |
I.v. Normal saline |
After arrival of patient to OT baseline vitalswill be recorded. Bispectral index (BIS) electrodes and TOF-Watch SX will be connected. A 18 or 20G peripheral intravenous cannula will be inserted. The bolus dose of i.v. normal saline 0.9% in equal volume will be given over 15 min prior to induction.. Pre oxygenation will be done with 100% oxygen for 3 min, intravenous fentanyl at 2μg/kg will be given. Injection propofol in titrated doses will be given until BIS 40-50 will be attained. After assessing ventilation Injection atracurium 0.5mg/kg will be used to provide muscle relaxation. After achieving zero twitch on Train of four monitoring, laryngoscopy will be done using Macintosh blade and endotracheal intubation will be done using appropriate size cuffed endotracheal tube within 30 seconds in a single attempt. Controlled ventilation using 66% N2O with O2 and sevoflurane will be used to maintain balance anaesthesia. Sevoflurane will be titrated to maintain intraoperative BIS readings between 40 and 60. Intermittent bolus of injection atracurium (0.1mgkg-1) will be given whenever one twitch will appear on TOF stimulation. Pneumoperitoneum will be produced by insufflating CO2 into the peritoneal cavity at a rate of 2 L/min and the intra-abdominal pressure will be kept between 12 and 14 mmHg. The patients will be mechanically ventilated with a circular system to maintain an EtCO2 of 35 to 40 mm Hg. Fentanyl 0.5μg/kg i.v. will be given if intraoperative HR and MAP increases by 20% or more than baseline .After the completion of surgery, anaesthetic agents will be stopped. Reversal agent will be given after getting all four responses to TOF stimulation. The patients will be extubated after reversal of the residual neuromuscular blockade using Injection glycopyrrolate 0.01mg/kg and injection neostigmine 0.05mg/kg and return of protective airway reflexes. When the patient will be in stable condition they will be shifted to recovery and observed for 1 hour. |
| Comparator Agent |
Injection dexmedetomidine |
After arrival of patient to OT baseline vitalswill be recorded. Bispectral index (BIS) electrodes and TOF-Watch SX will be connected. A 18 or 20G peripheral intravenous cannula will be inserted. The bolus dose of i.v. Dexmedetomidine in a dose 1μgkg-1 will be given over 15 min prior to induction.. Pre oxygenation will be done with 100% oxygen for 3 min, intravenous fentanyl at 2μg/kg will be given. Injection propofol in titrated doses will be given until BIS 40-50 will be attained. After assessing ventilation Injection atracurium 0.5mg/kg will be used to provide muscle relaxation. After achieving zero twitch on Train of four monitoring, laryngoscopy will be done using Macintosh blade and endotracheal intubation will be done using appropriate size cuffed endotracheal tube within 30 seconds in a single attempt. Controlled ventilation using 66% N2O with O2 and sevoflurane will be used to maintain balance anaesthesia. Sevoflurane will be titrated to maintain intraoperative BIS readings between 40 and 60. Intermittent bolus of injection atracurium (0.1mgkg-1) will be given whenever one twitch will appear on TOF stimulation. Pneumoperitoneum will be produced by insufflating CO2 into the peritoneal cavity at a rate of 2 L/min and the intra-abdominal pressure will be kept between 12 and 14 mmHg. The patients will be mechanically ventilated with a circular system to maintain an EtCO2 of 35 to 40 mm Hg. Fentanyl 0.5μg/kg i.v. will be given if intraoperative HR and MAP increases by 20% or more than baseline .After the completion of surgery, anaesthetic agents will be stopped. Reversal agent will be given after getting all four responses to TOF stimulation. The patients will be extubated after reversal of the residual neuromuscular blockade using Injection glycopyrrolate 0.01mg/kg and injection neostigmine 0.05mg/kg and return of protective airway reflexes. When the patient will be in stable condition they will be shifted to recovery and observed for 1 hour. |
| Intervention |
Injection Magnesium sulphate |
After arrival of patient to OT baseline vitalswill be recorded. Bispectral index (BIS) electrodes and TOF-Watch SX will be connected. A 18 or 20G peripheral intravenous cannula will be inserted. The bolus dose of i.v. magnesium sulphate in a dose 30mgkg-1 will be given over 15 min prior to induction.. Pre oxygenation will be done with 100% oxygen for 3 min, intravenous fentanyl at 2μg/kg will be given. Injection propofol in titrated doses will be given until BIS 40-50 will be attained. After assessing ventilation Injection atracurium 0.5mg/kg will be used to provide muscle relaxation. After achieving zero twitch on Train of four monitoring, laryngoscopy will be done using Macintosh blade and endotracheal intubation will be done using appropriate size cuffed endotracheal tube within 30 seconds in a single attempt. Controlled ventilation using 66% N2O with O2 and sevoflurane will be used to maintain balance anaesthesia. Sevoflurane will be titrated to maintain intraoperative BIS readings between 40 and 60. Intermittent bolus of injection atracurium (0.1mgkg-1) will be given whenever one twitch will appear on TOF stimulation. Pneumoperitoneum will be produced by insufflating CO2 into the peritoneal cavity at a rate of 2 L/min and the intra-abdominal pressure will be kept between 12 and 14 mmHg. The patients will be mechanically ventilated with a circular system to maintain an EtCO2 of 35 to 40 mm Hg. Fentanyl 0.5μg/kg i.v. will be given if intraoperative HR and MAP increases by 20% or more than baseline .After the completion of surgery, anaesthetic agents will be stopped. Reversal agent will be given after getting all four responses to TOF stimulation. The patients will be extubated after reversal of the residual neuromuscular blockade using Injection glycopyrrolate 0.01mg/kg and injection neostigmine 0.05mg/kg and return of protective airway reflexes. When the patient will be in stable condition they will be shifted to recovery and observed for 1 hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiology grade I and II between the age of 18-65 years, of either sex and posted for laparoscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with major hepatic, renal and endocrine dysfunction, cardiovascular dysfunction; neuromuscular, neurological disorder, atrioventricular conduction disturbance, COPD, asthma, obstructive sleep apnea and haematological disorders.
Patients with difficult airway.
Patients with known allergy to dexmedetomidine or magnesium sulphate.
Pregnancy, obesity (body mass index>30 kg m-2), hypertension, diabetes mellitus, and
major systemic illness
Patients on treatment with calcium channel blockers, beta-blockers, alpha 2 adrenergic agonists or
opioid abuse
Any intraoperative surgical complication like prolonged surgery (duration more than
two hours) or conversion to open surgery,
Patient’s unwillingness to participate in the study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in HR & MAP during laryngoscopy and intubation, creation & release of pneumoperitoneum and extubation. |
T0 baseline data
T1 following completion of study drug infusion
T2 1 minute after induction
T3 1 minute after intubation
T4 after peritoneal insufflation
T5 15 min after peritoneal insufflation T6 after peritoneal deflation
T7 1 min after extubation
T8 60 min after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe and compare intraoperative anaesthesia requirement, extubation time, time to first rescue analgesic requirement and postoperative sedation |
Intraop requirement of total propofol, fentanyl, muscle relaxant and mean end tidal sevoflurane concentration ;Extubation time; Duration of surgery; Time to first rescue analgesia- time from extubation to time when pain reported by patient was ≥4 on visual analogue scale. Injection paracetamol l5mg/kg IV will be used ,If the patient doesn’t get relief in 15 min Injection diclofenac 1.5mg/kg will be given; Post op sedation level will be assessed at 1,15,30, 60 min using Ramsay sedation score
|
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
Final Enrollment numbers achieved (Total)= "69"
Final Enrollment numbers achieved (India)="69" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/01/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study is to investigate the effect of dexmedetomidine and magnesium sulphate used as adjunct to general anaesthesia on perioperative haemodynamic response to laryngoscopy, intubation, pneumoperitoneum and extubation in patients undergoing laparoscopic cholecystectomy. |