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The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine

Primary Purpose

Nasal Polyps, Nasal Septum, Irregular, Functional Endoscopic Sinus Surgery

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Dexmedetomidine
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Polyps

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, Al-Azhar UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedtomidine group

ketamin group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
April 24, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05828199
Brief Title
The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine
Official Title
Comparative Evaluation The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine on Pain and Inflammatory Biomarkers in Patients Undergoing Nasal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps, Nasal Septum, Irregular, Functional Endoscopic Sinus Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedtomidine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ketamin group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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
Primary Outcome Measure Information:
Title
The postoperative pain
Description
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.
Time Frame
from 0 hours to 24 hours after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Gamal, assist.lect
Phone
01099549595
Email
ahmedgamal.226@azhar.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed AboElSuod, Assist.prof
Phone
01091945931
Email
mohamed.abdelgawad@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Essam Ali, Professor
Organizational Affiliation
Al-Azhar University, Faculty of medicine for boys
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Al-Azhar University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Essam Ali, Professor
Phone
01223215181
Email
essamalhalawany@gmail.com
First Name & Middle Initial & Last Name & Degree
Ibrahim Metwaly Bauomy, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine

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