a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects
Ultra Small Dose of Intrathecal Naloxone to Minimize Morphine Induced Side- Effects in Patients Undergoing Minor Anal Surgery Under Spinal Anesthesia. A Randomized Double Blind Study
1 other identifier
interventional
100
1 country
1
Brief Summary
I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis, nausea/emesis, constipation, urinary retention, respiratory depression and undesirable sedation) so using it as additive to intrathecal morphine in patients undergoing anal surgeries under spinal anesthesia may be beneficail
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 23, 2017
CompletedFirst Posted
Study publicly available on registry
July 26, 2017
CompletedOctober 4, 2017
October 1, 2017
9 months
July 23, 2017
October 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
post operative vomiting
vomiting and nausea incidence
24 hours
Secondary Outcomes (1)
pain
24 hour postoperatively
Study Arms (2)
group 1
ACTIVE COMPARATOR50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)
group 2
ACTIVE COMPARATOR50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\\ kg naloxone in 0.5 ml volume (total volume 2mL).
Interventions
50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)
50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\\ kg naloxone in 0.5 ml volume (total volume 2mL).
Eligibility Criteria
You may qualify if:
- ASA physical status I - II
- undergoing anal surgery with spinal anesthesia
You may not qualify if:
- Renal ,hepatic and cardiac patients -Infection at the site of injection.-
- Coagulopathy or other bleeding diathesis. -Preexisting neurologic deficits.-
- History of hypersensitivity to any of the given the drugs.
- Inability to communicate with the investigator and the hospital staff.
- History of chronic opioid use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emad Zarief Kamel Said
Asyut, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia and ICU
Study Record Dates
First Submitted
July 23, 2017
First Posted
July 26, 2017
Study Start
May 1, 2016
Primary Completion
February 1, 2017
Study Completion
April 1, 2017
Last Updated
October 4, 2017
Record last verified: 2017-10