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Gender and Opioid Consumption (GenderOpioid)

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ClinicalTrials.gov Identifier: NCT03006627
Recruitment Status : Unknown
Verified December 2016 by AlRefaey Kandeel, Mansoura University.
Recruitment status was:  Not yet recruiting
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
AlRefaey Kandeel, Mansoura University

Brief Summary:
Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models In this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding; analgesic duration (primary variable), frequency of analgesic requirement, total opioid consumption, Opioid related complications (respiratory depression, Nausea & vomiting, itching, over-sedation, delayed intestinal motility).

Condition or disease Intervention/treatment Phase
Postoperative; Parotitis Drug: postoperative morphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Male group
All male patients scheduled for upper abdominal surgeries
Drug: postoperative morphine
Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.

Active Comparator: Female group
All female patients scheduled for upper abdominal surgeries
Drug: postoperative morphine
Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.




Primary Outcome Measures :
  1. postoperative morphine consumption [ Time Frame: 24 hours after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I and II Cases scheduled for elective intraabdominal surgeries

Exclusion Criteria:

  • diabetes,
  • postmenopausal females,
  • laparoscopic surgery,
  • regional anesthesia emergency procedures,
  • sepsis,
  • hepatectomy,
  • Renal impairment, and
  • hepatic impairment,
  • mental and psychiatric disorders.
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Responsible Party: AlRefaey Kandeel, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT03006627    
Other Study ID Numbers: GenderOpioids
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents