Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment

NCT04976374 | Unknown

• 1 other identifier: AP2105-50105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of quality of post mastectomy analgesic protocol of Gabapentin and Dexmedetomedine in a placebo-controlled study

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Post operative morphine consumption

  Evaluation of the effects of combining and gabapentin and dexmedetomidine infusion on post operative morphine consumption within the first 24 h in patients undergoing modified radical mastectomy surgery

  24 hours

Secondary Outcomes (1)

• Post operative VAS score

  24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients of group A will start dexmedetomidine (precedex 100 ug lmL, Hospira) infusion 0.4 ug {Kg}h after bolus of 0.5 ug 1 kg intravenously over 10 min

Drug: Dexmedetomidine and Gabapentin

Group B

PLACEBO COMPARATOR

Group B will recive a bolus of saline then saline infusion identical to group A

Other: Saline

Interventions

Dexmedetomidine and Gabapentin DRUG

Administration of intravenous dexmedetomedine for post operative analgesic purposes in combination with gabapentin

Also known as: gabapentin

Group A

Saline OTHER

Intravenous Saline 0.9% for placebo purposes

Group B

Eligibility Criteria

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

You may qualify if:

• adult female patients below 65 years of age scheduled for modified radical mastectomy surgery, American society of Anesthesiologists(ASA) physical status I-II

You may not qualify if:

• known allergy to study drugs; patients already taking oral gabapentin, knal or hepatic defunction, current treatment with narcotics, antihypertensives, benzodiazepines, X2 agonists, antiepileptics and antipsychotics

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

NCI Egypt

Cairo, 02002, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Gabapentin; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

ahmed hu bakir, MD

CONTACT

01115661922; ahmed_bakir77@yahoo.com

Nasr ma Abdullah, MD

CONTACT

01005223734

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Intensive care and Pain Relief

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 26, 2021
• Study Start: May 25, 2021
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

EG (1)