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

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Urologic Endoscopic Surgery; Dexamethasone

Treatments: Drug: Bupivacaine Hydrochloride; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05549895

Intrathecal Dexamethasone

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Drug arm

Experimental group

Description:

45 patients will receive 8mg dexamethasone in addition to bupivacaine intrathecally .

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Dexamethasone

control arm

Other group

Description:

45 patients will receive only bupivacaine intrathecally as a control group.

Treatment:

Drug: Bupivacaine Hydrochloride