Dexmedetomidine Adjuvant to General Anesthesia of Abdominal Hysterectomy

NCT03600506 | Unknown

• 1 other identifier: 3400
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the effect of perioperative Dexmedetomidine infusion on Interleukin 6 and cortisol level in patients undergoing general anesthesia for total abdominal hysterectomy

Conditions

Effect of Drugs

Outcome Measures

Primary Outcomes (1)

• Change in Serum Interleukin 6 (IL6)

  Measurement of Serum Serum Interleukin 6 in picogram / milliliter

  At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively

Secondary Outcomes (10)

• Change in Serum Cortisol

  At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively

• Change in Mean arterial blood pressure

  Mean Arterial Blood Pressure before starting infusion of the study drug, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation

• Change in Heart Rate (HR)

  HR before starting infusion of the study drug, 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 in patient controlled analgesia (PCA)

  Twenty four hours after attachment of patient controlled analgesia in postoperative care unit

• Fentanyl consumption in microgram using questionnaire

  During intraoperative time

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Intervention drug of the study

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Normal Saline (Placebo)

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Patients will receive infusion of study drug intravenously 10 minutes before induction of anesthesia as 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr till the start of wound closure.

Also known as: Selective α2-agonist sympatholytic drug

Dexmedetomidine

Placebo DRUG

Fifty ml of Placebo (normal saline) will be prepared and given intravenously by a syringe pump over 10 minutes initially and then over 1 hour till the start of wound closure.

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiology physical status Grade I = (normal healthy patients)
• American Society of Anesthesiology physical status Grade II = (patients with mild systemic disease and no functional limitations)
• Patients scheduled for abdominal hysterectomy.

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.
• 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; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mohamed A Elsadany, MD

  Anesthesia Department, Faculty of Medicine, Suez Canal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A Elsadany, MD

CONTACT

00966541738161; sadany20@gmail.com

Abdelrahman M Elshwadfy, MD

CONTACT

00201027361545; abdelrahmanalshawadfy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 3, 2018

Record last verified: 2018-08