Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery

NCT05536362 | Completed Phase 1 DMC

• 1 other identifier: Nirvana Ahmed
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TCI propofol mixed with clonidine and ketamine

EXPERIMENTAL

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

Drug: TCI Propofol Injection

TCI propofol mixed with a placebo

EXPERIMENTAL

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

Drug: TCI Propofol Injection

Interventions

TCI Propofol Injection DRUG

To decrease postoperative pain after cancer colon surgery

Also known as: Ketamine and clonidine

TCI propofol mixed with a placebo; TCI propofol mixed with clonidine and ketamine

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I and II
• Patients with cancer colon

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

October 6 University Hospital

Giza, Cairo Governorate, 11311, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms; Pain, Postoperative

Interventions

Ketamine; Clonidine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nirvana Elshalakany, Professor

  Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: February 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 28, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

EG (1)