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

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Low speed
High speed
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypotension

Eligibility Criteria

17 Years - 45 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low speed

High speed

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

block level
demonstrate the effect of the injection speed on the level of block at 5 and 10 minutes
Number of participants experiencing nausea and vomiting
demonstrate the effect of the injection speed on nausea/vomiting

Full Information

First Posted
April 19, 2018
Last Updated
March 6, 2019
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03517683
Brief Title
Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section
Official Title
A Randomized Clinical Trial for the Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low speed
Arm Type
Experimental
Arm Description
Patients will receive intrathecal injection of the anesthetic mixture in a slow speed (1ml in 15 seconds)
Arm Title
High speed
Arm Type
Active Comparator
Arm Description
Patients will receive intrathecal injection of the anesthetic mixture in a high speed (1ml in 5 seconds)
Intervention Type
Other
Intervention Name(s)
Low speed
Intervention Description
Speed of intrathecal injection will be 1ml in 15 seconds
Intervention Type
Other
Intervention Name(s)
High speed
Intervention Description
speed of intrathecal injection will be 1ml in 5 seconds
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
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
Time Frame
within one hour
Secondary Outcome Measure Information:
Title
block level
Description
demonstrate the effect of the injection speed on the level of block at 5 and 10 minutes
Time Frame
5 and 10 minutes after performing the injection
Title
Number of participants experiencing nausea and vomiting
Description
demonstrate the effect of the injection speed on nausea/vomiting
Time Frame
within one hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

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

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