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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05549895
Other study ID # Intrathecal Dexamethasone
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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