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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517683
• Other study ID #: 24032016
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2019
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

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

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of participants experiencing nausea and vomiting	demonstrate the effect of the injection speed on nausea/vomiting	within one hour