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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05549895
Collaborator
(none)
90
2
30

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Total amount of fluids [intraoperative]

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

  2. Total amount of vasoactive drugs [Intraoperative]

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

Secondary Outcome Measures

  1. Blood pressure [Intraoperative and up to 1hour postoperative]

    systolic and diastolic blood pressure and mean arterial blood pressure.

  2. Post-operative VAS score of pain assessment. [Up to one hour postoperative]

    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).

  3. Post-operative shivering. [Up to 6 hours postoperatively.]

    shivering of the patient

  4. Post-operative nausea and vomiting. [Up to 6 hours postoperatively.]

    The presence of nausea or vomiting 6 hours post operatively

  5. Post dural puncture headache. [Up to 2 days postoperative]

    headache during 2 days postoperative and detection of severity and response to treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dalia Mohamed Abbas, Assistant lecture, Assiut University
ClinicalTrials.gov Identifier:
NCT05549895
Other Study ID Numbers:
  • Intrathecal Dexamethasone
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 30, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2022