The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine

Comparative Evaluation The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine on Pain and Inflammatory Biomarkers in Patients Undergoing Nasal Surgery

Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.

Study Overview

• Status: Recruiting
• Conditions: Nasal Polyps; Functional Endoscopic Sinus Surgery; Nasal Septum, Irregular
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Ketamine Hydrochloride

Detailed Description

The primary objective of anesthesia is balancing the patient's hemodynamics with the best possible surgical outcome. In modern anesthesia, a multimodal approach to balanced anesthesia is targeted with combined general anesthetics and systemic drugs.

Trans-nasal endoscopic surgery (TNES) is a helpful diagnostic and therapeutic modality in paranasal sinus diseases. TNES are associated with significant intraoperative bleeding, pain, epistaxis, and transient headaches .

Intra-operative surgical site bleeding is one major complication and all anesthetic techniques pursue the objective to reduce it to achieve better precision, reduced operative time, and faster postoperative wound healing.

Topical medications, surgical positioning, nasal packing, inhalational anesthetics, and systemic drugs are some of the documented methods.

Controlled hypotension is one of the methods to control bleeding. It reduces blood loss, enhances the operative field quality (dryness) and studies on hypotensive anesthesia have shown a statistically significant reduction in blood loss .

Several systemic drugs have been used to achieve controlled hypotension. However, they have their own set of limitations .

Dexmedetomidine, a highly selective α2 adrenoreceptor agonist, has anxiolytic, sedative, anesthetic, and analgesic properties. It has limited side effects in terms of respiratory depression. Because of these favorable properties, it is commonly used in a wide variety of procedures .

Dexmedetomidine is a relatively new drug approved at the end of 1999 by the Food and Drug Administration (FDA) for humans use for short-term sedationand analgesia (<24 hours) in the intensive care unit (ICU). Dexmedetomidine is a useful sedative agent with analgesic properties, hemodynamic stability and ability to recover respiratory function in mechanically ventilated patients facilitating early weaning .

Ketamine hydrochloride, a well-known anesthetic agent, has been in clinical use for more than four decades . Its antinociceptive-hypnotic effects are most likely the result of the noncompetitive antagonism at the N-methyl-D-aspartate (NMDA) receptor of the central nervous system .

Ketamine is used as an analgesic in low doses and as an anesthetic in high doses. It is suggested that ketamine maintains analgesia and reduces postoperative opioid use, whether used alone or in combination with other anesthetic agents, The perioperative use of ketamine in surgery with moderate-to-severe postoperative pain is recommended by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine, and American Society of Anesthesiologists.

Cytokines regulate the host response to infection, the immune response, inflammation, and trauma. Surgical stress has been reported to be associated with elevated cytokines response. IL-6 is highly expressed during inflammatory responses to conditions of stress, and can be used to assess the severity of surgical trauma.

The stress response to surgery is characterized by increased secretion of pituitary hormones and activation of the sympathetic nervous system, For example, release of corticotrophin from the pituitary stimulates cortisol secretion from the adrenal cortex .

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ahmed Gamal, assist.lect; Phone Number: 01099549595; Email: ahmedgamal.226@azhar.edu.eg
• Study Contact Backup: Name: Mohamed AboElSuod, Assist.prof; Phone Number: 01091945931; Email: mohamed.abdelgawad@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Medicine, Al-Azhar University
    • Contact: Essam Ali, Professor; Phone Number: 01223215181; Email: essamalhalawany@gmail.com
    • Sub-Investigator: Ibrahim Metwaly Bauomy, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Between 21 and 40 years of age, they with American Society of Anesthesiologists (ASA) physical status I-II and undergoing nasal and paranasal sinus surgery.

Exclusion Criteria:

• • Refusal to join the study.

  • Allergy to the drugs used in the study.
  • Drug and/or alcohol abuse.
  • Mental and psychiatric disorders.
  • Emergency operations.
  • Patients with systemic illnesses (eg, hypertension [ SBP >160 mm Hg], diabetes mellitus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedtomidine group; About 40 patients will receive bolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr.	Drug: Dexmedetomidine; bolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr
Active Comparator: ketamin group; About 40 patients will receive a ketamine bolus dose (0.3 mg/kg IV slowly), then continuous infusion dose of ketamine (0.2 mg/kg/hr).	Drug: Ketamine Hydrochloride; Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The postoperative pain	Assessed by VAS score.As (VAS:0-10, where 0 = no pain, and 10 = worst possible pain). Before surgery, all patients will be a short education about VAS.	from 0 hours to 24 hours after the procedure

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Essam Ali, Professor, Al-Azhar University, Faculty of medicine for boys

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 20, 2023

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Polyps; Nasal Polyps; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Dexmedetomidine
• Other Study ID Numbers: Ahmed Hegazy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No