Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery

NCT ID: NCT03344393

Last Updated: 2017-11-17

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-03-01

Brief Summary

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.The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.

Detailed Description

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I- Group K (ketamine): 30 patients will receive intraoperative intravenous ketamine infusion.

II- Group C (control): 30 patients will receive intraoperative intravenous normal saline infusion.

Conditions

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Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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ketamine hydrochloride

intravenous ketamine infusion in the intraoperative period

Group Type ACTIVE_COMPARATOR

Ketamine Hydrochloride

Intervention Type DRUG

intravenous ketamine infusion intraoperatively

normal saline

intravenous normal saline infusion in the intraoperative period

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

intravenous normal saline infusion intraoperatively

Interventions

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Ketamine Hydrochloride

intravenous ketamine infusion intraoperatively

Intervention Type DRUG

Normal saline

intravenous normal saline infusion intraoperatively

Intervention Type DRUG

Other Intervention Names

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ketalar Sodium chloride solution

Eligibility Criteria

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Inclusion Criteria

* \- Patient's status ASA status-I and II.
* Patients age above 18 years old.
* Patients scheduled for intestinal surgery.

Exclusion Criteria

* Patient refusal.
* Patients with known allergy to ketamine or morphine.
* Patients with significant hepatic dysfunction.
* Patients with severe renal disease.
* Significant Heart disease.
* Patients with chronic pain.
* Regular use analgesics, antidepressants or opioids in last 2 months.
* Any known convulsive disorder.
* Morbid obesity (BMI\>35).
* Patients with autoimmune disease
* Patients on corticosteroid therapy
* Pregnancy.
* Breast feeding.
* Woman under hormonal treatment.
* Oral disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed galal aly

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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mohamed aly, MD

Role: CONTACT

Phone: 00201062011126

Email: [email protected]

References

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Arikan M, Aslan B, Arikan O, Horasanli E, But A. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. Acta Cir Bras. 2016 Jan;31(1):67-73. doi: 10.1590/S0102-865020160010000010.

Reference Type BACKGROUND
PMID: 26840358 (View on PubMed)

Other Identifiers

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17200147

Identifier Type: -

Identifier Source: org_study_id