| CTRI Number |
CTRI/2020/06/026037 [Registered on: 22/06/2020] Trial Registered Prospectively |
| Last Modified On: |
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| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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To compare the effect of drug Dexmedetomidine with a placebo on the blood pressure and heart rate in patients undergoing Laparoscopic gall bladder removal surgery |
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Scientific Title of Study
|
EFFECT OF DEXMEDETOMIDINE INFUSION ON PERIOPERATIVE HAEMODYNAMIC STABILITY IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY: A PLACEBO CONTROLLED, RANDOMISED BLINDED STUDY |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dikshita Goswami |
| Designation |
Postgraduate trainee student |
| Affiliation |
Gauahti Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Guwahati, Kamrup
Bhangagarh, Guwahati, Kamrup, PIN 781032
Kamrup
ASSAM
781032
India |
| Phone |
7430953643 |
| Fax |
|
| Email |
dkshtgoswami@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Aldiona S Bhattacharyya |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital,Bhangagarh, Guwahati, Kamrup
Bhangagarh, Guwahati, Kamrup, PIN 781032
Kamrup
ASSAM
781032
India |
| Phone |
9101813237 |
| Fax |
|
| Email |
aldiona.shanpru1958@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Aldiona S Bhattacharyya |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital,Bhangagarh, Guwahati, Kamrup
Bhangagarh, Guwahati, Kamrup, PIN 781032
ASSAM
781032
India |
| Phone |
9101813237 |
| Fax |
|
| Email |
aldiona.shanpru1958@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Dr Dikshita Goswami |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Guwahati 781032, Assam |
| Type of Sponsor |
Other [Self] |
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Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aldiona S Bhattacharyya |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Guwahati 781032, Assam |
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dikshita Goswami |
Gauhati Medical College and Hospital |
Bhangagarh, Guwahati781032, Kamrup
Kamrup
ASSAM |
7430953643
dkshtgoswami@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Gauhati Medical College and Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Dexmedetomidine hydrochloride |
Intravenous infusion of Dexmedetomidine hydrochloride at the rate of 0.4 microgram per kilogram of body weight per hour in Sodium Chloride 0.9% via syringe pump starting from 10 minutes prior to induction of anaesthesia till the end of operation |
| Comparator Agent |
Placebo (Sodium Chloride 0.9%) |
Intravenous infusion of Sodium Chloride 0.9% via syringe pump starting from 10 minutes prior to induction of anaesthesia till the end of operation. The volume prepared and rate of infusion will be the same as that of intervention agent. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with valid consent
2) American Society of Anaesthesiologists Physical Status 1 or 2
3) Undergoing elective laparoscopic cholecystectomy requiring endotracheal intubation
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| ExclusionCriteria |
| Details |
1) Patient refusal
2) Patients having known allergy either to Dexmedetomidine or any of the drugs to be administered
3) Patients with airway problems (anticipated/ unanticipated difficult airway)
4) Pregnant or lactating females
5) Patients with known history of substance abuse
6) Patients with hypotension, bradycardia or pre existing heart block |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To evaluate the effect of Dexmedetomidine infusion on haemodynamic stability (Systolic and Diastolic Blood Pressure, Mean Arterial Pressure and Heart Rate) in response to the following events in patients undergoing laparoscopic cholecystectomy: laryngoscopy and endotracheal intubation, creation of pneumoperitoneum and extubation. |
Before starting infusion, 10 minutes after starting infusion, 1 minute after laryngoscopy and intubation, after pneumoperitoneum at- 1 minute, 15 minutes, 30 minutes, 45 minutes, 60 minutes and 1 minute after extubation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the effects on level of sedation at the end of surgery |
post operatively at 1 minute, 15 minutes, 30 minutes and 60 minutes after extubation |
| To oberve the effects on analgesia in immediate post operative period |
post operatively at 1 minute, 15 minutes, 30 minutes and 60 minutes after extubation |
| To record other relevant observations, if any |
From the start of infusion at 10 minutes prior to induction of anaesthesia till 60 minutes after extubation |
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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" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
23/07/2020 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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It will be sent for publication in peer reviewed journal once the trial is over |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
In the current era, laparoscopic cholecystectomy is considered the gold standard of treatment for cholelithiasis due to the benefits of better postoperative pain profiles, lesser surgical wound complications and reduced hospital stay.[1] Anaesthetic manoeuvres like direct laryngoscopy, tracheal intubation and extubation cause sympathetic stimulation. Moreover, the creation of pneumoperitoneum leads to an increase in plasma norepinephrine, epinephrine levels and plasma renin activity[2]. These changes lead to an increase in heart rate, blood pressure, systemic and pulmonary vascular resistance and reduced cardiac output[2]. The reverse Trendelenburg position required for the surgical procedure also leads to reduction in venous return thereby causing a further reduction in cardiac output[3]. The haemodynamic changes predispose the myocardium to ischaemia which may be life threatening in vulnerable patients[2]. In the past, various drugs like opioid analgesics, benzodiazepines, beta blockers, calcium channel blockers have been used to attenuate this stress response. α2 adrenergic agonists are increasingly being used to reduce stress response to anaesthesia and surgery for their analgesic, anxiolytic, sedative and sympatholytic properties[4,5]. Dexmedetomidine (an α2 agonist) is a commonly used drug which decreases sympathetic tone, arterial pressure and heart rate in a dose dependent manner and produces sedation without causing respiratory depression[3,4]. In this study, we intend to give intravenous infusion of Dexmedetomidine hydrochloride at the rate of 0.4 microgram per kilogram of body weight per hour in Sodium Chloride 0.9% starting from 10 minutes prior to induction of anaesthesia till the end of operation and compare it with intravenous infusion of Sodium Chloride 0.9% as placebo and observe the effects on haemodynamic stability following laryngoscopy and intubation, pneumoperitoneum and extubation. In this randomised controlled study, the null hypothesis that dexmedetomidine does not reduce heart rate and blood pressure in patients undergoing laparoscopic cholecystectomy would be investigated. REFERENCES: 1) 1) Samel SA, Patil BM, Nigalye N. Effect of Low Dose Dexmedetomidine Infusion on Hemodynamics in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Observational Study. Journal of Contemporary Medical Research. 2017;4(10):2069-74. 2) 2) Manne GR, Upadhyay MR, Swadia VN. Effects of low dose dexmedetomidine infusion on haemodynamic stress response, sedation and post-operative analgesia requirement in patients undergoing laparoscopic cholecystectomy. Indian journal of anaesthesia. 2014 Nov;58(6):726. 3) 3) Bhattacharjee DP, Nayek SK, Dawn S, Bandopadhyay G, Gupta K. Effects of dexmedetomidine on haemodynamics in patients undergoing laparoscopic cholecystectomy-A comparative study. Journal of Anaesthesiology Clinical Pharmacology. 2010 Jan 1;26(1):45. 4) 4) Rachit B, Nanda HS, Mahesh K. Evaluation of Dexmedetomidine-0.5 mu g/kg and 1 mu g/kg in Blunting the Responses to Laryngoscopy and Intubation. INTERNATIONAL JOURNAL OF SCIENTIFIC STUDY. 2016 Feb 1;3(11):147-53. 5) 5)Ghodki PS, Thombre SK, Sardesai SP, Harnagle KD. Dexmedetomidine as an anesthetic adjuvant in laparoscopic surgery: An observational study using entropy monitoring. Journal of anaesthesiology, clinical pharmacology. 2012 Jul;28(3):334.
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