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Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery

Primary Purpose

Colon Cancer, Post Operative Pain

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
TCI Propofol Injection
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • October 6 University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TCI propofol mixed with clonidine and ketamine

TCI propofol mixed with a placebo

Arm Description

Patient group,in which they got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine

Control group,in which they received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 7, 2022
Last Updated
October 24, 2022
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05536362
Brief Title
Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
Official Title
Consequences of Co-Administration of Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TCI propofol mixed with clonidine and ketamine
Arm Type
Experimental
Arm Description
Patient group,in which they got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine
Arm Title
TCI propofol mixed with a placebo
Arm Type
Experimental
Arm Description
Control group,in which they received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%)
Intervention Type
Drug
Intervention Name(s)
TCI Propofol Injection
Other Intervention Name(s)
Ketamine and clonidine
Intervention Description
To decrease postoperative pain after cancer colon surgery
Primary Outcome Measure Information:
Title
Measurement of Post-operative Pain
Description
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).
Time Frame
24-hour analgesic after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I and II Patients with cancer colon Exclusion Criteria: participants with a history of heart, renal and liver cell failure. allergic reaction to studied drugs, and history of epilepsy, hydrodynamic instability, chronic pain. mental illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirvana Elshalakany, Professor
Organizational Affiliation
Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 University Hospital
City
Giza
State/Province
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

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Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery

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