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Clinical Trials/CTRI/2024/07/069883
CTRI/2024/07/069883Not yet recruitingNot Applicable

The effect of Dexmedetomidine vs Magnesium sulphate for controlled hypotension in Spine surgeries

Kasturba Medical College1 site in 1 country50 target enrollmentStarted: July 15, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Locations
1
Primary Endpoint
Mean Arterial Pressure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Scheduled for spine surgery eg: Microdisectomy, fractures, disc herniation, decompression surgeries etc (limited to 4-6 hours)
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • 3.18 to 65 years of age.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Mean Arterial Pressure

Time Frame: 1.Basline vitals | 2.Every 15minutes till the surgery is over

Secondary Outcomes

  • 1.Surgical site visibility(2.Total blood loss)

Investigators

Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Ishita Gupta

Kasturba Medical College, Mangalore

Study Sites (1)

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