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Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery

Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05549895
Enrollment
90
Registered
2022-09-22
Start date
2022-09-30
Completion date
2022-10-31
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexamethasone, Urologic Endoscopic Surgery

Brief 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 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.

Interventions

DRUGDexamethasone

8 mg intrathecally

DRUGBupivacaine Hydrochloride

0.5 % intrathecally

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Age: \> 60 years old * Gender: Males and females * ASA grade I - II - III * Patients undergoing elective endoscopic urological procedures.

Exclusion criteria

* Patient refusal. * Suspected massive bleeding. * Transition to open abdominal surgery

Design outcomes

Primary

MeasureTime frameDescription
Total amount of fluidsintraoperativeTotal amount of fluids needed to maintain mean blood pressure more than 65 mmHg
Total amount of vasoactive drugsIntraoperativeTotal amount of vasoactive drugs needed to maintain mean blood pressure more than 65 mmHg

Secondary

MeasureTime frameDescription
Post-operative shivering.Up to 6 hours postoperatively.shivering of the patient
Blood pressureIntraoperative and up to 1hour postoperativesystolic and diastolic blood pressure and mean arterial blood pressure.
Post dural puncture headache.Up to 2 days postoperativeheadache during 2 days postoperative and detection of severity and response to treatment
Post-operative nausea and vomiting.Up to 6 hours postoperatively.The presence of nausea or vomiting 6 hours post operatively
Post-operative VAS score of pain assessment.Up to one hour postoperativeScores 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026