Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

NCT03060070 | Completed Phase 2

• 1 other identifier: 321
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.

Conditions

Postoperative Analgesia; Lower Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• postoperative rescue morphine consumption

  postoperative rescue morphine consumption

  24 hours postoperative

Study Arms (3)

control group,

PLACEBO COMPARATOR

saline in the same volume will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

Drug: Ketamine; Drug: dexmedetomidine

ketamine group,

ACTIVE COMPARATOR

ketamine in a dose of 0.5mg/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

Drug: dexmedetomidine; Drug: control group

dexmedetomidine group

ACTIVE COMPARATOR

dexmedetomidine in a dose of 1ug/kg will be added to the local anesthetic for TAP block in patients undergoing abdominal cancer surgery

Drug: Ketamine; Drug: control group

Interventions

Ketamine DRUG

Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block

control group,; dexmedetomidine group

dexmedetomidine DRUG

dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block

control group,; ketamine group,

control group DRUG

20ml of 0.25% bupivacaine will be injected in each side of the TAP block

dexmedetomidine group; ketamine group,

Eligibility Criteria

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

You may qualify if:

• All patients ASA I and II to whom abdominal surgery for cancer will be conducted will be included in the study

You may not qualify if:

• Coagulopathies
• ASA III or IV, patient refusal, sensitivity to the used drugs

Sponsors & Collaborators

• Assiut University: lead
• South Egypt Cancer Institute: collaborator

Study Sites (1)

South Egypt Cancer Institute

Asyut, Assiut University, 171516, Egypt

Location

MeSH Terms

Interventions

Ketamine; Dexmedetomidine; Control Groups

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associte professor

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: March 10, 2017
• Primary Completion: June 25, 2017
• Study Completion: July 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

EG (1)