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

Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery and Its Effect on Salivary Cortisol and Alpha Amylase Levels

.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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Drug: Ketamine Hydrochloride; Drug: Normal saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ketamine hydrochloride; intravenous ketamine infusion in the intraoperative period	Drug: Ketamine Hydrochloride; intravenous ketamine infusion intraoperatively; Other Names: ketalar
Active Comparator: normal saline; intravenous normal saline infusion in the intraoperative period	Drug: Normal saline; intravenous normal saline infusion intraoperatively; Other Names: Sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	IV PCA	2 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cortisol level	salivary	2 days postoperative
alpha amylase level	salivary	2 days postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 17200147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No