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Gender and Opioid Consumption

NCT ID: NCT03006627

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Postoperative; Parotitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Male group

All male patients scheduled for upper abdominal surgeries

Group Type ACTIVE_COMPARATOR

postoperative morphine

Intervention Type DRUG

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.

Female group

All female patients scheduled for upper abdominal surgeries

Group Type ACTIVE_COMPARATOR

postoperative morphine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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AlRefaey Kandeel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GenderOpioids

Identifier Type: -

Identifier Source: org_study_id