NCT03517683

Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section

Completed NA Last updated 7 March 2019

What this trial tests

NA trial testing Low speed in Hypotension in 159 participants. Completed in 31 January 2019.

Timeline

15 April 2018

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Makassed General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	159
Start date	15 April 2018
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	1 location across Lebanon

Drugs / interventions tested

• Low speed
• High speed

Conditions studied

• Hypotension — all drugs for Hypotension →

Sponsor

Makassed General Hospital

Who can join

Adults 17 to 45, female only, with Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hypotension is the most common complication of neuraxial anesthesia in obstetric patients and its prevalence in cesarean section is about 50-90%. Maternal hypotension causes unpleasant symptoms such as nausea, vomiting, loss of consciousness, respiratory depression, and cardiac arrest. Hypotension may reduce placental perfusion and result in fetal acidosis and neurological injury. Several techniques have been proposed to prevent hypotension.

The recommended spinal block height to ensure patient comfort for Cesarean delivery is T4-6. Clinically, it is desirable that the spread of local anesthetic through the cerebrospinal fluid (CSF) achieves a sensory level no higher than the T4 dermatome to avoid extensive sympathetic block. It is also important that the spinal block level be no lower than T6 to avoid patient discomfort during peritoneal manipulation and uterine exteriorization. The effect of injection speed on spread of spinal anesthesia is controversial. Several studies have demonstrated more extensive spread with faster injection while others report either greater spread with slower injection, or no difference. Slow injection of hyperbaric bupivacaine 10 mg over 60 and 120 sec has been shown to reduce the incidence and severity of hypotension during Cesarean delivery under spinal anesthesia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.