Clinical Trial: Granisetron in Diabetic Parturients Decrease Spinal Induced Hypotension

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Attenuation of Spinal Induced Hypotension With Granisetron in Type I Diabetic Parturients

Brief Summary: Diabetic Parturients are exposed to intraoperative hypotension after spinal anesthesia and we proposed that intravenous Granisterone 1 mg will attenuate the hypotension occurred with spinal block during Cesarean sections.

Detailed Summary:

Introduction:

Spinal anesthesia is considered the first choice for cesarean sections if there are no absolute or relative contraindications. It is easy and has lower risks for mother and baby for most of cases. Anesthetists, especially junior staff, prefer spinal anesthesia for cesarean sections avoiding managing airway or inserting an endotracheal tube which is usually difficult in full term pregnant woman.

Hypotension that follows spinal anesthesia usually occur due to blockade of sympathetic vasomotor activity that is accentuated by compression of the aorta and inferior vena cava by the gravid uterus when the patient is in the supine position.

It starts very soon after intrathecal injection of the local anesthetic and may extend till the end of the block putting the anesthesia team in an explanatory situation. The pathophysiology of spinal hypotension is mainly due to the sympathetic blockade predominating pararsympathetic power to dilating blood vessels and subsequent blood pooling in the dilated blood vessels (mainly venous side).

Sudden bradycardia can occur from shift in cardiac autonomic balance toward the parasympathetic system from activation of left ventricular mechanoreceptors or chemoreceptors Bezold Jarisch reflex (BJR) or from an increase in baroreflex activity.[1] Serotonin released during low-volume states has been suggested as a possible trigger for the BJR.[2] Granisetron is a 5-Hydoxy Tryptamine 3 (5-HT3) receptor antagonist that is very effective in preventing nausea and vomiting.

Diabetes mellitus is a widespread disease that increases the risk of cardiovascular diseases and intraoperative mortalities. Diabetes is associated with increased risk of periop
Sponsor: Suez Canal University

Current Primary Outcome: Incidence of Hypotension [ Time Frame: 15 minutes after spinal anesthesia ]

incidence of hypotension with systolic blood pressure less than 90 mmHg


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of bradycardia [ Time Frame: 15 minutes after spinal anesthesia ]

Incidence of bradycardia with Heart Rate less than 50 beats / minutes


Original Secondary Outcome: Same as current

Information By: Suez Canal University

Dates:
Date Received: March 21, 2017
Date Started: May 1, 2017
Date Completion: November 1, 2017
Last Updated: April 24, 2017
Last Verified: April 2017