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

NCT05549895 | Unknown Phase 4

• 1 other identifier: Intrathecal Dexamethasone
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dexamethasone; Urologic Endoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• Total amount of fluids

  Total amount of fluids needed to maintain mean blood pressure more than 65 mmHg

  intraoperative

• Total amount of vasoactive drugs

  Total amount of vasoactive drugs needed to maintain mean blood pressure more than 65 mmHg

  Intraoperative

Secondary Outcomes (5)

• Blood pressure

  Intraoperative and up to 1hour postoperative

• Post-operative VAS score of pain assessment.

  Up to one hour postoperative

• Post-operative shivering.

  Up to 6 hours postoperatively.

• Post-operative nausea and vomiting.

  Up to 6 hours postoperatively.

• Post dural puncture headache.

  Up to 2 days postoperative

Study Arms (2)

Drug arm

EXPERIMENTAL

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

Drug: Dexamethasone; Drug: Bupivacaine Hydrochloride

control arm

OTHER

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

Drug: Bupivacaine Hydrochloride

Interventions

Dexamethasone DRUG

8 mg intrathecally

Drug arm

Bupivacaine Hydrochloride DRUG

0.5 % intrathecally

Drug arm; control arm

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexamethasone; Bupivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: September 22, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09