| CTRI Number |
CTRI/2024/07/069883 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Controlled hypotension in spine surgeries |
|
Scientific Title of Study
|
The effect of Dexmedetomidine vs Magnesium sulphate for controlled hypotension in Spine surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishita Gupta |
| Designation |
PG Student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Light House hill road
Mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
8447150240 |
| Fax |
|
| Email |
ishita1.kmcmlr2023@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sumesh T Rao |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Light House hill road
Mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9449167895 |
| Fax |
|
| Email |
sumesh.rao@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Sumesh T Rao |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Light House hill road
Mangalore
KARNATAKA 575001 India |
| Phone |
9449167895 |
| Fax |
|
| Email |
sumesh.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College
Lighthouse hill road
Mangalore
575001 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Lighthouse hill road
Mangalore
575001 |
| Type of Sponsor |
Private 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 Ishita Gupta |
Kasturba Medical college Hospital |
Department of Anaesthesiology
Kasturba medical college
Lighthouse hill road
Mangalore Dakshina Kannada KARNATAKA |
8447150240
ishita1.kmcmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba medical college, Mangalore |
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 |
Dexmedetomidine (Group D) |
Loading dose: In Group D, patients will be administered 1μg/kg (intravenous) dexmedetomidine in 100 mL saline solution 10 min before surgery.
Maintainence dose:In Group D, 0.5-1 μg/kg/h (intravenous) dexmedetomidine will be administered during surgery.
The maintenance dose will be given till the surgeon starts to close the surgery
Total duration: 6 months
The surgical team will be blinded to group allocation. |
| Comparator Agent |
Magnesium sulphate (Group M) |
Loading dose: In Group M, patients will be administered 40 mg/kg magnesium sulfate(intravenously) in 100 mL saline solution 10 min before surgery.
Maintainence dose: In group M, 10-15 μg/kg/h (intravenously) magnesium sulphate will be given during surgery.
The maintenance dose of these drugs will be given till the surgeon starts to close the surgery
Total duration: 6 months
The surgical team will be blinded to group allocation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Scheduled for spine surgery eg: Microdisectomy, fractures, disc herniation, decompression surgeries etc (limited to 4-6 hours)
2. American Society of Anesthesiologists (ASA) physical status I-II.
3.18 to 65 years of age
|
|
| ExclusionCriteria |
| Details |
1.Known allergy to dexmedetomidine or magnesium sulfate
2.History of uncontrolled cardiovascular disease
3.History of neurological disease
4.Severe renal impairment
5.Hepatic disease
6.Coagulopathy
7.Patient refusal
8.hypotension is not achieved by these drugs with in 30min intraoperatively
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Arterial Pressure |
1.Basline vitals
2.Every 15minutes till the surgery is over |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Surgical site visibility
2.Total blood loss
3.Surgeons’ satisfaction
4.Adverse effects |
1. Surgical field bleeding will be evaluated every 15minutes
2. At the end of surgery the comparison of total blood loss
and the surgeons satisfaction on the field visibility |
|
|
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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sumesh.rao@manipal.edu].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Controlled hypotension is a technique to reduce blood loss and the need for blood transfusion during surgery by improving the visibility of surgical site and decreasing the blood pressure until hypotension is achieved. Nowadays, newer and more sensitive spine surgery devices are getting introduced like microsurgical techniques and minimally invasive techniques which has successfully made to stabilize every segment of the spine. In spine surgeries, there are chances of increased bleeding due to the close network of epidural venous plexus. Due to increased bleeding and decreasing the visibility of the surgical field there is an increased chance of severing a nerve. Controlled hypotension means to reduce Mean Arterial Pressure (MAP) to 60-70 mmHg or a 30% decrease in the baseline value. Decrease in intraoperative blood pressure leads to a direct reduction in bleeding from surgically injured arteries and arterioles. This decreases the intraoperative blood loss and facilitates surgical exposure and further reduces transfusion dependence. Numerous pharmacological agents have succeeded in controlling MAP. The ideal agent used for controlled hypotension should be easy to administer, have a short onset time, effect that disappears quickly when administration is discontinued, rapid elimination without toxic metabolites, negligible effects on vital organs and predictable and dose-dependent effects.
Magnesium sulphate Magnesium sulphate causes hypotension by : 1. limiting the outflow of calcium from the sarcoplasmic reticulum 2. acts as a vasodilator by increasing the synthesis of prostacyclin 3. inhibiting angiotensin converting enzyme (ACE) activity. Magnesium sulphate also has analgesic action due to its antagonistic effect at N-methyl D-aspartate (NMDA) receptors which inhibits norepinephrine release by blocking N-type and partially L-type calcium channels. Dexmedetomidine Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, anxiolytic and analgesic characteristics. Dexmedetomidine activates central 2A and imidazoline type 1 receptors which causes decrease in norepinephrine release and leads to a decrease in blood pressure and heart rate. There have not been many studies comparing the effect of magnesium sulphate and dexmedetomidine with each other in spine surgeries. Hence our study aims to bridge the gap between these two drugs for achieving hypotension to decrease bleeding and increase the surgical visibility without any adverse effects of the drug. This observational study is designed with the aim of obtaining clinical evidence on a potentially different effect of dexmedetomidine versus magnesium sulphate in hypotensive anaesthesia during spine surgery. |