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

A Randomized Clinical Trial for the Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Other: Low speed; Other: High speed

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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Makassed General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low speed; Patients will receive intrathecal injection of the anesthetic mixture in a slow speed (1ml in 15 seconds)	Other: Low speed; Speed of intrathecal injection will be 1ml in 15 seconds
ACTIVE_COMPARATOR: High speed; Patients will receive intrathecal injection of the anesthetic mixture in a high speed (1ml in 5 seconds)	Other: High speed; speed of intrathecal injection will be 1ml in 5 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Makassed General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2018
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (ACTUAL): May 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: 24032016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No