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

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03344393
• Other study ID #: 17200147
• Status: Not yet recruiting
• Phase: N/A
• First received: November 9, 2017
• Last updated: November 13, 2017
• Start date: December 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: mohamed aly, MD
• Phone: 00201062011126
• Email: galalm1967[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

.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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Drug:
• Ketamine Hydrochloride
intravenous ketamine infusion intraoperatively
• Normal saline
intravenous normal saline infusion intraoperatively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption	IV PCA	2 days postoperative
Secondary	cortisol level	salivary	2 days postoperative
Secondary	alpha amylase level	salivary	2 days postoperative