Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07302815

Preemptive Intravenous Micro-dose Dexmedetomidine to Prevent Emergence Agitation in Adult Patients Undergoing Septoplasty Surgeries

This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta university

Tanta, Gharbia Governorate, 31527, Egypt

About this study

Emergence agitation (EA) is characterised by confusion, restlessness or aggressive behaviour during recovery from general anaesthesia. EA is more common following ear, nose, & throat (ENT) surgery. The exact cause and pathophysiology of EA are unknown, although risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting, otolaryngology operations, and the use of inhalational anesthetics particularly sevoflurane. EA might cause injury, accidental removal of intravenous cannulation, self-extubation, post-operative wound bleeding and increase the nursing requirements in the post-anesthesia care unit (PACU). There are limited studies concerning adult EA, and although its prevalence is less than child EA, it carries more risk of injury due to serious uncontrolled behaviors. Intravenous (IV) anesthetics, sedatives and opioids are the most frequently utilized medications to manage EA, with variable success rates and significant potential to delay recovery and cause undesirable side-effects. Dexmedetomidine is a highly selective α2 agonist which produces sedation and anxiolysis through reduction in sympathetic central nervous system activity. It has a major advantage over other sedatives; it is associated with minimal respiratory depression. According to a recent meta-analysis, intraoperative administration of dexmedetomidine decreases postoperative pain and the incidence of EA in adults. Considering the short length of corrective nasal reduction surgery (CR), an intraoperative infusion of dexmedetomidine as an anesthetic adjuvant may prolong the anesthesia and recovery time. Low dose infusion of dexmedetomidine (0.2 µg /kg/h) has been reported to reduce incidence of EA and opioid consumption effectively in elderly patients undergoing cancer surgeries under GA. Previous studies have shown that a single dose of dexmedetomidine, not as a premedication, is also effective in reducing EA and facilitating smooth extubation after pediatric adenotonsillectomy. Also recent study reported the efficacy of pre-operative dexmedetomidine administration (1 μg/kg) in preventing EA in adults undergoing CR of a nasal bone fracture. Up till now no clinical studies investigated the efficacy of single pre-operative micro dose of dexmedetomidine in prevention of EA, so in this clinical study we hypothesize that preoperative micro dose of dexmedetomidine may be beneficial in mitigation of EA in short timed Septoplasty surgeries safely and without prolongation of recovery time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients of both gender aged 18 to 60 years with American Society of Anesthesiologists (ASA) Physical Status I or II, who were scheduled for septoplasty surgery under general anesthesia.

Exclusion criteria

  • Patients declined to participate in the trial.
  • History or clinical evidence of chronic obstructive pulmonary disease.
  • History of renal or hepatic dysfunction, sleep apnea syndrome.
  • Cognitive dysfunction or psychiatric disorder.
  • Patients receiving beta blocker.
  • Patients with anticipated difficult airway.
  • Patients with electro cardiac abnormalities.
  • Emergency surgeries.
  • Pregnancy.

Treatment and study plan

Dexmedetomidine

Drug

micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Saline

Drug

50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Primary outcomes

  1. Incidence of emergence agitation

    Time frame: incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

    using Aono's Four-Point Scale (Aono Scale) which is a simple and widely used tool to assess emergence agitation (EA). It categorizes agitation during emergence from anesthesia into four levels.

    • calm_ Patient is quiet and not agitated.
    • Not calm but can be easily consoled _ Slight restlessness but settles with verbal reassurance or mild physical comfort.
    • Moderately agitated _ Patient is crying or difficult to console but not combative.
    • Severely agitated _Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff.

    Scores 3-4 indicate clinically relevant emergence agitation.

Secondary outcomes

  1. severity of emergence agitation

    Time frame: severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

    Aono's Scale grades the intensity of a patient's agitation during emergence from anesthesia (3) Moderately agitated - Patient is crying or difficult to console but not combative.

    (4) Severely agitated - Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff.

  2. extubation time

    Time frame: Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

    Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

  3. Length of stay in the post anesthetic care unit (PACU).

    Time frame: time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

    Total time a patient spends in the PACU from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

  4. Intraoperative opioid consumption

    Time frame: from induction of anesthesia until completion of surgery

    Total amount of opioid medications administered to a patient during the entire surgical procedure, from induction of anesthesia until completion of surgery

  5. Post operative numerical rating scale score (NRS)

    Time frame: - NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery

    The Numerical Rating Scale (NRS) is a validated tool used to assess a patient's pain intensity by having them assign a number to their pain on a 0-10 scale.

    On a scale from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Preemptive Intravenous Micro-dose Dexmedetomidine to Prevent Emergence Agitation in Adult Patients Undergoing Septoplasty Surgeries: A Randomized Placebo Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.