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

NCT ID: NCT05549895

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2022-10-31

Brief Summary

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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

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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

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Dexamethasone Urologic Endoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Drug arm

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

8 mg intrathecally

Bupivacaine Hydrochloride

Intervention Type DRUG

0.5 % intrathecally

control arm

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

Group Type OTHER

Bupivacaine Hydrochloride

Intervention Type DRUG

0.5 % intrathecally

Interventions

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Dexamethasone

8 mg intrathecally

Intervention Type DRUG

Bupivacaine Hydrochloride

0.5 % intrathecally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Mohamed Abbas

Assistant lecture

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Intrathecal Dexamethasone

Identifier Type: -

Identifier Source: org_study_id