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

Dexamethasone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05549895
• Other study ID #: Intrathecal Dexamethasone
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2022
• Est. completion date: October 2022

Study information

• Verified date: September 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Dexamethasone

Intervention

Drug:
• Dexamethasone
8 mg intrathecally
• Bupivacaine Hydrochloride
0.5 % intrathecally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of fluids	Total amount of fluids needed to maintain mean blood pressure more than 65 mmHg	intraoperative
Primary	Total amount of vasoactive drugs	Total amount of vasoactive drugs needed to maintain mean blood pressure more than 65 mmHg	Intraoperative
Secondary	Blood pressure	systolic and diastolic blood pressure and mean arterial blood pressure.	Intraoperative and up to 1hour postoperative
Secondary	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
Secondary	Post-operative shivering.	shivering of the patient	Up to 6 hours postoperatively.
Secondary	Post-operative nausea and vomiting.	The presence of nausea or vomiting 6 hours post operatively	Up to 6 hours postoperatively.
Secondary	Post dural puncture headache.	headache during 2 days postoperative and detection of severity and response to treatment	Up to 2 days postoperative