DexamethasonePhase 4NCT05549895
Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery
A Phase 4 study testing Dexamethasone and Bupivacaine Hydrochloride in people with Dexamethasone and Urologic Endoscopic Surgery, run by Assiut University.
Trial summary
Correction of Post-spinal anesthesia hypotension by fluids pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance Many advantages were investigated for the addition of… Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexamethasone, Urologic Endoscopic Surgery
- What is being tested?
- Dexamethasone and Bupivacaine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Oct 2022
- Phase
- Phase 4
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: > 60 years old
- Gender: Males and females
- ASA grade I - II - III
- Patients undergoing elective endoscopic urological procedures.
Who cannot join
- Patient refusal.
- Suspected massive bleeding.
- Transition to open abdominal surgery
About this study
Correction of Post-spinal anesthesia hypotension by fluids pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering.
In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.
Read the detailed description
Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgery. Spinal anesthesia avoids the risks of general anesthesia such as aspiration of gastric contents and difficulty with airway management.
Post-spinal anesthesia hypotension in elderly patients is challenging. Correction of Post-spinal anesthesia hypotension by fluids either colloids or crystalloids or by vasoconstrictors pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance.
Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering. Avoidance of complications of opioids is a great issue as, postoperative nausea, vomiting, respiratory depression, urinary retention, prolonged hospital stay and immunosuppression.
In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.
- Conditions
- Dexamethasone, Urologic Endoscopic Surgery
- Being tested
- Dexamethasone, Bupivacaine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
8 mg intrathecally
Bupivacaine HydrochlorideDrug
0.5 % intrathecally
| Study group | Role | What they receive |
|---|---|---|
| Drug arm | Experimental | 45 patients will receive 8mg dexamethasone in addition to bupivacaine intrathecally . Receives: Drug: Dexamethasone; Drug: Bupivacaine Hydrochloride |
| control arm | Other | 45 patients will receive only bupivacaine intrathecally as a control group. Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of fluids
Total amount of fluids needed to maintain mean blood pressure more than 65 mmHg
Measured: intraoperative
Total amount of vasoactive drugs
Total amount of vasoactive drugs needed to maintain mean blood pressure more than 65 mmHg
Measured: Intraoperative
Secondary outcomes (5)
Blood pressure
systolic and diastolic blood pressure and mean arterial blood pressure.
Measured: Intraoperative and up to 1hour postoperative
Post-operative VAS score of pain assessment.
Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Measured: Up to one hour postoperative
Post-operative shivering.
shivering of the patient
Measured: Up to 6 hours postoperatively.
Post-operative nausea and vomiting.
The presence of nausea or vomiting 6 hours post operatively
Measured: Up to 6 hours postoperatively.
Post dural puncture headache.
headache during 2 days postoperative and detection of severity and response to treatment
Measured: Up to 2 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexamethasoneStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549895
- Sponsor's protocol ID
- Intrathecal Dexamethasone
- Status last verified
- Sep 2022
- First submitted
- 27 May 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery
- ClinicalTrials.gov ID
- NCT05549895
- Acronym / sponsor ID
- Intrathecal Dexamethasone
- Conditions
- Dexamethasone, Urologic Endoscopic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 Sep 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.
Correction of Post-spinal anesthesia hypotension by fluids pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering.
In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.
Detailed description
Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgery. Spinal anesthesia avoids the risks of general anesthesia such as aspiration of gastric contents and difficulty with airway management.
Post-spinal anesthesia hypotension in elderly patients is challenging. Correction of Post-spinal anesthesia hypotension by fluids either colloids or crystalloids or by vasoconstrictors pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance.
Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering. Avoidance of complications of opioids is a great issue as, postoperative nausea, vomiting, respiratory depression, urinary retention, prolonged hospital stay and immunosuppression.
In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug arm | Experimental | Drug: Dexamethasone, Drug: Bupivacaine Hydrochloride45 patients will receive 8mg dexamethasone in addition to bupivacaine intrathecally . |
| control arm | Other | Drug: Bupivacaine Hydrochloride45 patients will receive only bupivacaine intrathecally as a control group. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: > 60 years old
- Gender: Males and females
- ASA grade I - II - III
- Patients undergoing elective endoscopic urological procedures.
Key exclusion criteria (3 listed)
- Patient refusal.
- Suspected massive bleeding.
- Transition to open abdominal surgery
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 |
|---|---|---|
| Dexamethasone8 mg intrathecally | Drug | Drug arm |
| Bupivacaine Hydrochloride0.5 % intrathecally | Drug | Drug arm, control arm |
Primary outcome
Total amount of fluids
Time frame: intraoperative
Total amount of fluids needed to maintain mean blood pressure more than 65 mmHg
Total amount of vasoactive drugs
Time frame: Intraoperative
Total amount of vasoactive drugs needed to maintain mean blood pressure more than 65 mmHg
5 secondary outcomes
Blood pressure
Time frame: Intraoperative and up to 1hour postoperative
Post-operative VAS score of pain assessment.
Time frame: Up to one hour postoperative
Post-operative shivering.
Time frame: Up to 6 hours postoperatively.
Post-operative nausea and vomiting.
Time frame: Up to 6 hours postoperatively.
Post dural puncture headache.
Time frame: Up to 2 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Bupivacaine Hydrochloride in people with Dexamethasone and Urologic Endoscopic Surgery, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Total amount of fluids (time frame: intraoperative). The study lists 2 primary outcomes in all. 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 30 Sep 2022.