Dexamethasone Intravenous Versus Intrathecal in Spinal Anesthesia

NCT ID: NCT05470530

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2022-07-15

Brief Summary

The purpose of this study is to compare the the effect of intravenous and the intrathecal dexamethasone when added to spinal anesthesia in cesarean section.

Detailed Description

1. Pre-operative settings:

Detailed preoperative examination and preoperative investigations (complete blood picture, Bleeding Time, prothrombin time and partial thromboplastin time) were performed. Age and weight were recorded. The patient was fasting for 8 hours preoperatively.

In the preanesthetic room, 18-gauge intravenous cannula was sited. Patients was preloaded with 5 mL/kg of lactated Ringer's solution over 20 minutes. The visual analogue scale (VAS) for pain was explained to the patients

2. Intra-operative Settings Inside the operating room, mean arterial blood pressure (MAP), heart rate (HR), electrocardiography (ECG) and peripheral oxygen saturation (SpO2) were obtained using standard non-invasive monitors and base line values were recorded.

The spinal technique was performed under complete aseptic condition with the patient in sitting position at the L3- L4 or L4 -L5 intervertebral space with 25-gauge spinal needle through midline approach. The spinal drugs were administered over 30 second according to each group.

Groups:

The eligible patients were enrolled in this double blinded study and randomly allocated to one of three groups by computer generated random number lists. The allocation was concealed using closed opaque envelopes. The solution for intrathecal injection was prepared by an anesthesiologist who did not have a further role in the study.

Control group (n= 22): Participants were received normal saline 2 mL intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL (10mg) plus 1 mL of 0.9% saline, overall 3 ml volume intrathecally (Pyasetska, 2020).

IT group (n= 22): Participants were received normal saline 2 mL intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL (10mg) plus 0.5 mL (2mg) dexamethasone diluted in 0.5 ml of 0.9% saline, overall 3 ml volume intrathecally. The dose of 2mg of dexamethasone was demonstrated by Amer (2018) to be the least effective intrathecal dose.

IV group (n= 22): Participants were received dexamethasone 2 mL (8mg) intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL plus 1 mL of 0.9% saline (Pyasetska, 2020).

After completing the intrathecal injection, the patient was immediately placed in the supine position IV Ringer's solution 10 ml/kg/hour was administered throughout the surgery. Oxygen was administered through a nasal cannula in a rate of 2 L/min.

Measurements:

Sensory block was assessed according to loss of sensation using cold alcohol swab every two minutes after completing the spinal injection. Time to reach the sensory level of T10 was recorded to determine the effect of the drug on the onset of the spinal anesthesia.

Spinal anesthesia was considered adequate to undergo surgery if the sensory level reaches a T4 level, otherwise the patients were excluded from the study, recorded as "excluded due to low level" and replaced by another patient to achieve the required sample size.

The highest level reached within 30 min, and its time, were recorded. Hemodynamic parameters (heart rate and mean arterial pressure) and SpO2 were measured and recorded just after performing spinal anesthesia, and at 10 min interval till the end of the surgery.

Bradycardia, defined as a heart rate decrease more than 20% of the baseline (preoperative) value, will be treated by atropine 0.6 mg IV.

Hypotension, defined as a decrease in MAP more than 20% of the baseline value, will be treated by IV ephedrine 3 mg IV increments.

Episodes of bradycardia and hypotension and doses of administered drugs for treatment were recorded.

A decrease of SpO2 below 92% was treated by increasing the oxygen flow rate and management of the airway if necessary. The occurrence of this event was recorded.

Occurrence of side effects as nausea, vomiting, itching or shivering were recorded.

Time to two-segment regression of the sensory block from the highest level. The level was assessed every 10 minutes, after reaching the highest sensory level, by loss of sensation to cold alcohol swab. This time was considered as the duration of the sensory block

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IT group

Participants were received normal saline 2 mL intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL (10mg) plus 0.5 mL (2mg) dexamethasone diluted in 0.5 ml of 0.9% saline, overall 3 ml volume intrathecally. The dose of 2mg of dexamethasone was demonstrated by Amer (2018) to be the least effective intrathecal dose.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Dexamethasone was given either intrathecal or intravenous in spinal anesthesia during ceaseran section while normal saline was given in control group

IV group

Participants were received dexamethasone 2 mL (8mg) intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL plus 1 mL of 0.9% saline

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Dexamethasone was given either intrathecal or intravenous in spinal anesthesia during ceaseran section while normal saline was given in control group

Interventions

Dexamethasone

Dexamethasone was given either intrathecal or intravenous in spinal anesthesia during ceaseran section while normal saline was given in control group

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female patients in childbearing period with an age of 18 years up to 40 years old scheduled to undergo elective cesarean section under spinal anesthesia.

All patients were of ASA II physical status with uncomplicated pregnancy and no comorbidity.

Exclusion Criteria

• Refusal of procedure or participation in the study by patients. Emergency cesarean section. Any contraindication to spinal anesthesia as infection at site of injection or history or evidence of coagulopathy.

Congenital anomaly of the spine. Psychiatric illness affecting the ability to properly communicate with the patient or to use the VAS for pain.

Receiving analgesics or corticosteroid drugs. Allergies to drugs used.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Emam

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa M Mohamed, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Faculty of Medicine Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS 179/2022

Identifier Type: -

Identifier Source: org_study_id