Clinical trial NCT05549895: Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery
Official title: Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dexamethasone
Urologic Endoscopic Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total amount of fluids
timeFrame: intraoperative
measure: Total amount of vasoactive drugs
timeFrame: Intraoperative
Secondary outcomes:
measure: Blood pressure
timeFrame: Intraoperative and up to 1hour postoperative
measure: Post-operative VAS score of pain assessment.
timeFrame: Up to one hour postoperative
measure: Post-operative shivering.
timeFrame: Up to 6 hours postoperatively.
measure: Post-operative nausea and vomiting.
timeFrame: Up to 6 hours postoperatively.
measure: Post dural puncture headache.
timeFrame: Up to 2 days postoperative
Other outcomes:
Locations:
Study officials:
References: