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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03164590
Other study ID # 388
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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