Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial
Effective intraoperative and postoperative pain management is critical for patient comfort and recovery, yet traditional methods for assessing pain under general anaesthesia are limited by their subjective nature and reliance on vital signs. Automated pupillometry, which gives the parameters of the pupillary light reflex (PLR) components, offers an objective and quantitative approach to evaluating nociception and pain.
This study aims to evaluate the effectiveness of the automated pupillometry in enhancing early postoperative pain control and to assess its utility in guiding opioid administration during the perioperative period.
A prospective, non-blinded randomized controlled trial will be conducted with 68 patients undergoing laparotomy for gastrointestinal surgery. Participants will be randomly assigned to either an interventional group, where analgesia is guided by automated pupillometry measurements, or a control group receiving standard pain management. Key outcomes include the time to first rescue analgesia, self-reported pain scores, opioid consumption. The automated pupillometry measurements will be taken at key surgical moments, including before induction, pre-incision, and during recovery.
Pain scores and rescue analgesia use will be compared between groups using appropriate statistical tests, and Kaplan-Meier survival curves will analyze time to first rescue analgesia. Regression analyses will explore the relationship between pupillometry readings and postoperative pain.
It is anticipated that the automated pupillometry guided group will experience longer intervals before requiring rescue analgesia and report lower pain scores, suggesting improved pain management and reduced opioid use.
This study could validate automated pupillometry as an innovative tool for optimizing postoperative pain management, potentially improving patient outcomes by enabling more precise and effective analgesia in surgical settings.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Kuala Lumpur
-
Kuala Lumpur、Kuala Lumpur、マレーシア、59100
- Universiti Malaya Medical Centre
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 1. Patients aged 18 - 70 years old scheduled for elective/emergency laparotomy with clear awareness and good communication
- 2. ASA (American Society of Anaesthesiologists) physical status I-III
- 3. Expected to have moderate to severe pain in the early postoperative period
Exclusion Criteria:
- 1. Patient with known pupillary abnormality (such as anisocoria, pharmacologic dilation, previous intraocular surgery)
- 2. Pre-existing neurological disorder affecting pupillary reflexes
- 3. Patients on chronic opioid therapy or with a history of substance abuse
- 4. Non-consenting patients or those with cognitive impairments affecting informed consent
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Intervention
Participants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction. Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml, titrated according to the anaesthetist's discretion. TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline. Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure. Additional analgesics could be administered as control arm. At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min.Anaesthetists will give rescue morphine when the pupillary diameter changes > 20% and repeat the measurement after 5 minutes |
Participants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction.
Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml.
TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline after induction.
The automated pupillometry measurement is repeated 5 mins after increment.
Prior to skin closing, IV morphine 0.1 mg/kg during skin closing and automated pupillometry measurement is repeated to aim pupillary diameter is within 20% of baseline.
Analgesics is titrated according to the anaesthetist's discretion and reason is documented if it is deviated from the protocol.
For both arms, automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision, during skin closure, at PACU 10 mins and at PACU 30 mins. For intervention arm only, the additional automated pupillometry measurement will be performed after administration of analgesia. |
|
他の：Control
Participants in the control group will receive anaesthetic and analgesic management as per the standard practice followed by the attending anaesthetist.
Additional analgesics, including intravenous paracetamol, intravenous parecoxib, and abdominal plane blocks, will be provided if there are no contraindications.
Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure.
At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min.
|
For both arms, automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision, during skin closure, at PACU 10 mins and at PACU 30 mins. For intervention arm only, the additional automated pupillometry measurement will be performed after administration of analgesia. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
post operative opioid consumption
時間枠：first 24 hours post operatively
|
the amount of post operative opioid consumption including rescue analgesia and patient controlled analgesia morphine usage would be recorded
|
first 24 hours post operatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The correlation between pupillary response metrics (% change, constriction velocity, dilatation velocity, NPi) and opioid dosage administered.
時間枠：automated pupillometry measurements will be done before induction, after induction, before skin incision, during skin incision, after skin incision, during skin closure, and at post anaesthesia recovery unit 10 min and 30 min.
|
To find the measurement changes or correlation with opioiod administration, and to analyse it statistically
|
automated pupillometry measurements will be done before induction, after induction, before skin incision, during skin incision, after skin incision, during skin closure, and at post anaesthesia recovery unit 10 min and 30 min.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 202541314965
- BKP004-2025-ECRG (その他の助成金/資金番号：EARLY CAREER RESEARCH GRANT (BKP-ECRG) 2025 UNIVERSITI MALAYA)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。