NCT05226325

Brief Summary

The aim of work to assess the effect of different doses of Dexmedetomidine when used as an adjuvant to entropy-guided general anesthesia on the intraoperative surgical field quality, inhaled anesthesia consumption and postoperative analgesia requirement during FESS surgeries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

January 6, 2022

Last Update Submit

November 9, 2022

Conditions

Pain ManagementDexmedetomidineAnesthesia

Keywords

EntropyFESS

Outcome Measures

Primary Outcomes (1)

  • Surgical field quality using Fromme et al 6-point bleeding scale

    0 No bleeding (cadaveric conditions) 1. Slight bleeding - no suctioning required 2. Slight bleeding - occasional suctioning required 3. Slight bleeding - frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed 4. Moderate bleeding - frequent suctioning required and bleeding threatens surgical field directly after suction is removed 5. Severe bleeding - constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely compromised

    Through operative time, an average of 1 to 2 hours

Secondary Outcomes (8)

  • Intraoperative hemodynamics including MAP (mmHg)

    Through operative time, an average of 1 to 2 hours

  • Intraoperative hemodynamics including HR ( beats/min.)

    Through operative time, an average of 1 to 2 hours

  • End tidal isoflurane concentration needed to maintain SE 40-60

    Through operative time, an average of 1 to 2 hours

  • End tidal isoflurane concentration needed to maintain RE 40-60

    Through operative time, an average of 1 to 2 hours

  • The duration of anesthesia and recovery time

    Through operative and recovery time, an average of 3 to 4 hours

  • +3 more secondary outcomes

Study Arms (3)

G0.2

ACTIVE COMPARATOR

(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.2 mcg/kg/hour

Drug: Dexmedetomidine

G0.4

ACTIVE COMPARATOR

(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.4 mcg/kg/hour

Drug: Dexmedetomidine

G0.6

ACTIVE COMPARATOR

(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.6 mcg/kg/hour

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minute followed by infusion

G0.2G0.4G0.6

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiology (ASA) Class I or II undergoing elective functional endoscopic sinus surgery.

You may not qualify if:

  • American Society of Anaesthesiology (ASA) Class ≥ III
  • Allergy or hypersensitivity to Dexamedetomidine.
  • History of myocardial dysfunction.
  • Cardiac dysrhythmia and Heart block
  • Patients receiving beta blockers or calcium channel blockers
  • Patient refusal
  • Patient with known history of hepatic or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 6, 2022

First Posted

February 7, 2022

Study Start

February 15, 2022

Primary Completion

July 25, 2022

Study Completion

August 2, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Locations

EG(1)