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

NCT03517683 | Completed

• 1 other identifier: 24032016
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  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

  within one hour

Secondary Outcomes (2)

• block level

  5 and 10 minutes after performing the injection

• Number of participants experiencing nausea and vomiting

  within one hour

Study Arms (2)

Low speed

EXPERIMENTAL

Patients will receive intrathecal injection of the anesthetic mixture in a slow speed (1ml in 15 seconds)

Other: Low speed

High speed

ACTIVE COMPARATOR

Patients will receive intrathecal injection of the anesthetic mixture in a high speed (1ml in 5 seconds)

Other: High speed

Interventions

Low speed OTHER

Speed of intrathecal injection will be 1ml in 15 seconds

Low speed

High speed OTHER

speed of intrathecal injection will be 1ml in 5 seconds

High speed

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of Anesthesia and Pain Management Department

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 7, 2018
• Study Start: April 15, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

LE (1)