Adjuvant to General Anesthesia in Patients Undergoing Major Abdominal Surgeries

NCT03600493 | Unknown Phase 4 DMC

• 1 other identifier: 3399
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

assessing the effect of perioperative infusion of Dexmedetomidine versus Lidocaine on neuro endocrine stress response to surgery and anesthesia

Conditions

Stress Related Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Serum Interleukin 6 (IL6)

  Serum Interleukin 6 will be measured in picogram/Milliliter

  Serum Interleukin 6 will be measured at baseline and then 2 hours after induction of surgery and then 6 hours postoperative

Secondary Outcomes (7)

• Change in Serum Cortisol

  Serum Cortisol will be measured as baseline and then 2 hours after induction of surgery and then 6 hours postoperative

• Changes in Mean Arterial Blood Pressure (MABP)

  Baseline MABP, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation

• Changes in Heart Rate (HR)

  Baseline HR, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation

• Morphine consumption

  Morphine consumption during first 24 hours postoperatively

• Ephedrine

  During intraoperative period

Study Arms (2)

Dexemetomidine

ACTIVE COMPARATOR

Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure.

Drug: Dexmedetomidine

Lidocaine

ACTIVE COMPARATOR

Lidocaine prepared in a syringe with the same volume of Dexmedetomidine to assure blinding given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure.

Drug: Lidocaine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure.

Also known as: Selective Alpha 2 agonist

Dexemetomidine

Lidocaine DRUG

Lidocaine given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure.

Also known as: Lignocaine

Lidocaine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both gender.
• Consent from patients about technique and nature of the study.
• Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II).
• Patients scheduled for major abdominal surgery.

You may not qualify if:

• Pre-operative regular medication with opioids and benzodiazepines, alcohol abuse, known sleep disturbance, known endocrine disease
• Known allergy to Dexmedetomidine or Lidocaine.
• History of endocrine disorders.
• Heart block greater than first degree.
• Medication known to affect the sympathetic response or hormonal secretion.
• Smokers.

Sponsors & Collaborators

• Suez Canal University: lead

MeSH Terms

Interventions

Dexmedetomidine; Lidocaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mohamed A Elsadany, MD

  Anesthesia and Intesive Care department, Faculty of Medicine, Suez Canal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A Elsadany, MD

CONTACT

00966541738161; Sadany20@gmail.com

Ahmed M Elewa, MD

CONTACT

00201002744572; Ahmedabdelrahman29@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 3, 2018

Record last verified: 2018-08