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

Overview

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.

Full Title of Study: “A Randomized Clinical Trial for the Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2019

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 .

Interventions

  • Other: Low speed
    • Speed of intrathecal injection will be 1ml in 15 seconds
  • Other: High speed
    • speed of intrathecal injection will be 1ml in 5 seconds

Arms, Groups and Cohorts

  • Experimental: Low speed
    • Patients will receive intrathecal injection of the anesthetic mixture in a slow speed (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)

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of hypotension
    • Time Frame: 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 Measures

  • block level
    • Time Frame: 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
    • Time Frame: within one hour
    • demonstrate the effect of the injection speed on nausea/vomiting

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 17 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Makassed General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zoher Naja, Chairperson of Anesthesia and Pain Management Department – Makassed General Hospital

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