Attenuation of Airway and Cardiovascular Responses to Extubation in Chronic Smokers

NCT04659642 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: dexmedetomidine in anesthesia
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this blind comparative study was to compare the effects of dexmedetomidine, fentanyl and their combination on airway reflexes and hemodynamic responses to tracheal extubation in Adult chronic male smoking patients scheduled for abdominal surgeries (of average 2-3 hours duration).

Conditions

Airway Responses; Hemodynamic

Keywords

extubation; chronic smoker; dexmedetomidine; fentanyl; abdominal surgery

Outcome Measures

Primary Outcomes (2)

• Quality of extubation by extubation quality score

  1. No coughing 2. Smooth extubation, minimal coughing (1 or 2 times) 3. Moderate coughing (3 or 4 times) 4. Severe coughing (5-10 times) and straining 5. Poor extubation, very uncomfortable (laryngospasm and coughing \>10 times).

  5 minutes

• post extubation laryngospasm, bronchospasm or desaturation

  laryngospasm, bronchospasm or desaturation

  30 minutes

Secondary Outcomes (3)

• Time to extubation

  up to 25 minutes

• Hemodynamic responses

  up to 60 minutes

• • Postoperative agitation and sedation were evaluated on a 10 points scale (RASS Scale)

  up to 30 minutes

Study Arms (3)

dexmedetomidine group (group A)

ACTIVE COMPARATOR

will receive Dexmedetomidine 1ug/kg body weight IV diluted to 100ml normal saline (NS) over 15 minutes.

Drug: Dexmedetomidine Injection [Precedex]

Fentanyl group (group B)

ACTIVE COMPARATOR

will receive Fentanyl 1 ug/kg body weight IV diluted to 100 ml normal saline (NS) over 15 minutes.

Drug: Fentanyl Citrate Injection

Both Dexmedetomidine and fentanyl group (group C)

ACTIVE COMPARATOR

will receive both Dexmedetomidine 1ug/kg body weight mixed with fentanyl 1ug/kg in 100 ml normal saline (NS) over 15 minutes.

Combination Product: dexmedetomidine and fentanyl

Interventions

Dexmedetomidine Injection [Precedex] DRUG

the drug is given 15 minutes before the estimated end of surgery

dexmedetomidine group (group A)

Fentanyl Citrate Injection DRUG

the drug is given 15 minutes before the estimated end of surgery

Fentanyl group (group B)

dexmedetomidine and fentanyl COMBINATION_PRODUCT

the combination of the two drugs with the same used doses is given 15 minutes before the estimated end of surgery

Both Dexmedetomidine and fentanyl group (group C)

Eligibility Criteria

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

You may qualify if:

• Chronic cigarette smokers (patients have smoked for two years at least, and a minimum consumption of 10 cigarettes/ day)
• American Society of Anesthesiologists (ASA) II.
• Normotensive and receiving no medications
• Body mass index of 30 kg/m2
• Mallampati classification I-II

You may not qualify if:

• History of opioid, sedative drugs or medications affecting heart rate or blood pressure.
• Morbid obesity.
• Current upper respiratory infection
• Hypovolemia
• IHD
• History of sleep apnea or Difficult Intubation.
• Emergency procedures.
• Hepatic or renal impairment.
• Drug allergy to Dexmeditomidine or fentanyl.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

NCI, Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• naglaa abdullah, prof

  NCI, Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

asmaa abdulwahhab, M.sc

CONTACT

1212959293; asmafhmy@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 9, 2020
• Study Start: November 30, 2020
• Primary Completion: March 6, 2021
• Study Completion: March 20, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

EG (1)