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.
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.
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
- 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
- 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 group | Role | What they receive |
|---|---|---|
| IT group | Active comparator | 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. Receives: Drug: Dexamethasone |
| IV group | Active comparator | 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 Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted22 Jul 2022
- Study start10 Mar 2022
- Primary completion10 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Emam, Ain Shams University
- Investigators
- Marwa M Mohamed, Lecturer, Principal investigator, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Intravenous Versus Intrathecal in Prolonging the Duration of Spinal Anesthesia and Postoperative Analgesia in Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT05470530
- Acronym / sponsor ID
- FMASU MS 179/2022
- Conditions
- Healthy
- Keywords
- Dexamethasone, spinal anesthesia, cesarean section
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IT group | Active comparator | Drug: DexamethasoneParticipants 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 | Active comparator | Drug: DexamethasoneParticipants were received dexamethasone 2 mL (8mg) intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL plus 1 mL of 0.9% saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone was given either intrathecal or intravenous in spinal anesthesia during ceaseran section while normal saline was given in control group | Drug | IT group, IV group |
Primary outcome
Duration of sensory block in spinal anesthesia
Time frame: 4 months after starting the study
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa M Mohamed, Lecturer principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
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.