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HealthyPhase 1NCT05470530

Dexamethasone Intravenous Versus Intrathecal in Spinal Anesthesia

A Phase 1 study testing Dexamethasone in people with Healthy, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteEgypt
Study dates
10 Mar 2022to 15 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine Ain Shams University

    Cairo

Other trials in Egypt

About this study

Official title: Dexamethasone Intravenous Versus Intrathecal in Prolonging the Duration of Spinal Anesthesia and Postoperative Analgesia in Elective Cesarean Section

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.

Read the 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
Being tested
Dexamethasone
Keywords
Dexamethasone, spinal anesthesia, cesarean section

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

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

Study groups in NCT05470530
Study groupRoleWhat they receive
IT groupActive comparatorParticipants 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.
Receives: Drug: Dexamethasone
IV groupActive comparatorParticipants were received dexamethasone 2 mL (8mg) intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL plus 1 mL of 0.9% saline
Receives: Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of sensory block in spinal anesthesia

    The primary objective of this study is to compare the efficacy of intrathecal dexamethasone with dexamethasone when used intravenously as an adjuvant to prolong the sensory block obtained by spinal anaesthesia and postoperative analgesia in cesarean section

    Measured: 4 months after starting the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2022
  2. Study start10 Mar 2022
  3. Primary completion10 Jul 2022
  4. Study completion15 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05470530
Sponsor's protocol ID
FMASU MS 179/2022
Status last verified
Jul 2022
First submitted
20 Jul 2022
Last updated
22 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexamethasone in people with Healthy, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of sensory block in spinal anesthesia (time frame: 4 months after starting the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.

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