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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05536362
Other study ID # Nirvana Ahmed
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 1, 2021
Est. completion date February 28, 2022

Study information

Verified date October 2022
Source Egymedicalpedia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Study Showed that combining clonidine and ketamine together can increase the likelihood of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and inflammation.


Description:

This study aimd to determine whether propofol infusion combined with clonidine and ketamine is more efficient in lowering the level of IL-8, preserving operation stability, and dropping post-operative pain and morphine intake. When paralleled to propofol alone, TIVA employing propofol infusion along with pre-operation clonidine and ketamine is effective at preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake. For this study, sixty contestants with ASA physical status I and II, ranging in age from 35 to 65, were scheduled for colon cancer operation lasting longer than 120 minutes. This study excluded participants with a history of heart, renal and liver cell failure, allergic reaction to studied drugs, and history of epilepsy, hemodynamic instability, chronic pain, or mental illness. Using a computer-generated randomization list, the patients were randomly allocated into two groups (30 patients each). The treated group(Group T),which got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine, the control group(Group C),which received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%) .A third party was included in this study so neither the researchers nor the research subjects are aware of the intervention which the patients got.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 28, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 35 Years to 65 Years
Eligibility Inclusion Criteria: 1. ASA physical status I and II 2. Patients with cancer colon Exclusion Criteria: 1. participants with a history of heart, renal and liver cell failure. 2. allergic reaction to studied drugs, and history of epilepsy, 3. hydrodynamic instability, 4. chronic pain. 5. mental illness.

Study Design


Intervention

Drug:
TCI Propofol Injection
To decrease postoperative pain after cancer colon surgery

Locations

Country Name City State
Egypt October 6 University Hospital Giza Cairo

Sponsors (1)

Lead Sponsor Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of Post-operative Pain Assessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain). 24-hour analgesic after surgery
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