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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dexamethasone; Urologic Endoscopic Surgery
• Intervention / Treatment: Drug: Dexamethasone; Drug: Bupivacaine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug arm; 45 patients will receive 8mg dexamethasone in addition to bupivacaine intrathecally .	Drug: Dexamethasone; 8 mg intrathecally; Drug: Bupivacaine Hydrochloride; 0.5 % intrathecally
Other: control arm; 45 patients will receive only bupivacaine intrathecally as a control group.	Drug: Bupivacaine Hydrochloride; 0.5 % intrathecally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	systolic and diastolic blood pressure and mean arterial blood pressure.	Intraoperative and up to 1hour postoperative
Post-operative VAS score of pain assessment.	Scores 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).	Up to one hour postoperative
Post-operative shivering.	shivering of the patient	Up to 6 hours postoperatively.
Post-operative nausea and vomiting.	The presence of nausea or vomiting 6 hours post operatively	Up to 6 hours postoperatively.
Post dural puncture headache.	headache during 2 days postoperative and detection of severity and response to treatment	Up to 2 days postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: September 18, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: Intrathecal Dexamethasone

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No