Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines

Endometrial Adenocarcinoma Clinical Trial

Official title:

Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Inflammatory Cytokines Response After Total Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164590
• Other study ID #: 388
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I-II patients

• age range (18-60) years,

• weight (50- 90) kg

Exclusion Criteria:

• allergy to study drugs

• significant cardiac disease

• respiratory disease

• renal disease

• hepatic disease

Related Conditions & MeSH terms

• Adenocarcinoma
• Endometrial Adenocarcinoma

Intervention

Drug:
• Ketamine
patients receive local anesthetic wound infiltration with 1 mg /kg ketamine
• dexmedetomidine
patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine
• bupivacaine
patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline

Locations

Country	Name	City	State
Egypt	South Egypt Cancer instIitute	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of pain at rest and on coughing	severity of pain at rest and on coughing will be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 = worst imaginable pain)	24 hours
Secondary	sedation	sedation by using sedation score	24 hours