Gender and Opioid Consumption

Postoperative; Parotitis Clinical Trial

— GenderOpioid  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03006627
• Other study ID #: GenderOpioids
• Status: Not yet recruiting
• Phase: N/A
• First received: December 27, 2016
• Last updated: December 29, 2016
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative; Parotitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative morphine consumption		24 hours after surgery	Yes