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

M

Makassed General Hospital

Status

Completed

Conditions

Hypotension

Treatments

Other: High speed
Other: Low speed

Study type

Interventional

Funder types

Other

Identifiers

NCT03517683
24032016

Details and patient eligibility

About

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 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 .

Enrollment

159 patients

Sex

Female

Ages

17 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

159 participants in 2 patient groups

Low speed
Experimental group
Description:
Patients will receive intrathecal injection of the anesthetic mixture in a slow speed (1ml in 15 seconds)
Treatment:
Other: Low speed
High speed
Active Comparator group
Description:
Patients will receive intrathecal injection of the anesthetic mixture in a high speed (1ml in 5 seconds)
Treatment:
Other: High speed

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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