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

Not Applicable

Completed

• Conditions: Hypotension
• Interventions: Other: High speed; Other: Low speed

• Registration Number: NCT03517683
• Lead Sponsor: Makassed General Hospital

Brief Summary

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.

Detailed Description

Patients admitted to undergo elective c-section under spinal anesthesia will be randomized using the sealed envelope technique to Group I who will receive intrathecal injection in a slow speed 1ml in 15 sec and group II who will receive 1ml in 5 sec.

The baseline pulse rate, blood pressure, respiratory rate, and oxygen saturation will be recorded intraoperatively. The presence of preoperative hypotension, nausea and vomiting, and level of block at 5 and 10 mins post intrathecal injection will be assessed .

Study Timeline

• Study Start: 2018-04-15
• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-07
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

Inclusion Criteria

• Patients with American Society of Anesthesiology physical status 1 and 2
• and scheduled for elective c-section surgery under spinal anesthesia

Exclusion Criteria

• Patients with cardiac and psychological problems
• Patients who take sedatives or narcotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High speed	High speed	Patients will receive intrathecal injection of the anesthetic mixture in a high speed (1ml in 5 seconds)
Low speed	Low speed	Patients will receive intrathecal injection of the anesthetic mixture in a slow speed (1ml in 15 seconds)

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	within one hour	demonstrate the effect of the injection speed (high and low) of the anesthesia mixture intrathecally on the incidence of hypotension measured through mean arterial pressure

Secondary Outcome Measures

Name	Time	Method
block level	5 and 10 minutes after performing the injection	demonstrate the effect of the injection speed on the level of block at 5 and 10 minutes
Number of participants experiencing nausea and vomiting	within one hour	demonstrate the effect of the injection speed on nausea/vomiting

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon