NCT04168879

Brief Summary

nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration 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

November 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

November 10, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

November 16, 2019

Last Update Submit

May 24, 2024

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

  • Postoperative emergence agitation

    ramsy hunt sedation agitation score used during emergence from anesthesia

    2 hour

Secondary Outcomes (4)

  • postoperative opioid consumption

    24 hour

  • surgical field quality

    2 hours

  • consumed inhalational anesthesia

    2 hours

  • postoperative pain

    2 hours

Other Outcomes (1)

  • intraoperative bleeding

    2 hours

Study Arms (2)

bupivacaine group

ACTIVE COMPARATOR
Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution

saline group

PLACEBO COMPARATOR
Drug: normal saline

Interventions

Bupivacaine 0.5% Preservative-Free Injectable SolutionDRUG

1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used to block the sphenopalatine ganglion by ultrasound guided suprazygomatic approach

bupivacaine group
normal salineDRUG

1.5 ml of normal saline is delivered to the sphenopalatine ganglion by ultrasound guided suprazygomatic approach

saline group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patient written consent
  • elective surgery
  • age 18 - 55 year old

You may not qualify if:

  • patient refusal
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71111, Egypt

Location

Related Publications (1)

  • Hamed R, Gamal L, Elsawy S, Baker MA, Abbas YH. Efficacy of ultrasound guided sphenopalatine ganglion block in management of emergence agitation after sinoscopic nasal surgery: a randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101429. doi: 10.1016/j.accpm.2024.101429. Epub 2024 Oct 2.

    PMID: 39366653DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

BupivacaineSaline Solution

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

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

Study Record Dates

First Submitted

November 16, 2019

First Posted

November 19, 2019

Study Start

November 10, 2021

Primary Completion

December 10, 2023

Study Completion

December 10, 2023

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)