Clinical trial NCT06963749: Surgical Intervention in Deep Sedation: No Pain or no Memory
Official title: Pain Control During Brief Intervention in Deep Sedation: no Pain or no Memory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Acute
Surgical Procedure, Unspecified
Keywords: Deep sedation
Nociception
NOL index
Pain control
Lead sponsor: ASL Novara
Sponsor class: OTHER_GOV
First posted: 2025-05-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients from the Ss. Trinità Hospital in Borgomanero between March 1, 2024, and August 31, 2024, who are to undergo surgical procedures lasting less than 90 minutes and particularly painful, with an indication for deep sedation anesthesia.

Brief summary: The goal of this observational study is to assess the levels of nociception in deeply sedated patients who need painful and short-duration surgical procedure.

The main question it aims to answer is to verify that the sedative protocols used in clinical practice are sufficiently effective also in terms of nociception.

Participants will deeply sedated and monitored with PMD-200™ to detect the nociception level (NOL Index).

Detailed description: Prior to enrollment, upon arrival in the operating room and after being properly positioned on the operating table, patients will undergo standard intraoperative monitoring with pulse oximetry (SpO2), 3-lead electrocardiography (ECG), non-invasive brachial blood pressure monitoring (BP), a sensor for the Bispectral Index (BIS), and a nociception sensor (NOL) will also be placed.

Patients will be pre-oxygenated with a face mask with inspired oxygen fraction (FiO2) at 100% for 3 minutes.

The induction phase of deep sedation anesthesia will be conducted with a single bolus of Fentanyl 1 mcg/kg and total intravenous anaesthesia - target controlled infusion (TIVA-TCI) Propofol with an effect site concentration (Cε) of 4.0 mcg/mL.

Once the sedation level shows a Bispectral Index between 40 and 60, observation of the NOL Index will begin.

Subsequently, the laryngeal mask can be positioned, mechanical ventilation started, and the surgical procedure commenced.

During this phase, the maintenance of the anesthetic plan will be ensured by the infusion of Propofol in TIVA-TCI (with a Cε that keeps the BIS between 40 and 60) and the administration of Paracetamol 1 g, Ketorolac 30 mg, and Dexamethasone 4 mg.

At the end of the surgical procedure, the observation of the NOL Index will conclude.

Upon awakening, patients will be taken to the Post-Anesthesia Care Unit (PACU), where they will remain until their vital parameters are stabilized. At this point, 15 minutes post-operatively, the intensity of pain will be recorded using the numeric pain rating scale (NRS) scale.

Subsequently, patients will be transferred to the ward, where, 2 hours post-operatively, they will be interviewed about the intensity of post-operative pain and whether they need any rescue analgesic doses.

Data collection and management will be handled by the investigator and/or the designated study staff.

Data will be collected directly into a digital file (spreadsheet - MS Excel - Microsoft, Redmond, CA) without the use of paper forms.

Data will be collected anonymously without identifying codes that could link to the patient's medical record and identity. The correspondence list between demographic data and the patients' identification codes will be kept at the enrolling center and will only be accessible to the study staff.

The data to be collected include the following:

1. Anthropometric Data:

   1. Sex
   2. Age
   3. Weight
   4. Height
   5. Body Mass Index (BMI)
   6. American Society of Anesthesiologists (ASA) Physical Status
2. Clinical Data

   1. Surgical Procedure Performed
   2. Heart Rate (HR)
   3. Non-Invasive Blood Pressure (BP)
   4. Pulse Oximetry (SpO2)
   5. Bispectral Index (BIS)
   6. NOL Index
   7. NRS Pain Scale

Continuous variables will be presented as mean and standard deviation or as median and interquartile range depending on their distribution. Normal distribution will be assessed using the Kolmogorov-Smirnov test. Any sub-analyses and comparisons between sub-groups will be conducted using the Student's t-test for parametric data, while the Mann-Whitney test will be used for non-parametric data. Categorical variables will be presented as absolute numbers and percentages of the total sample. Any sub-analyses and comparisons between sub-groups will be conducted using the Chi-square test or Fisher's exact test, depending on the size of the sub-groups. In all cases, the null hypothesis will be rejected for α values \<0.05. The software used for data analysis and sample size calculation is MedCalc v. 22.013 (MedCalc Software, Ostend, Belgium).

Eligibility criteria: Inclusion Criteria:

* Adult patient
* ASA Physical Status I - II - III

Exclusion Criteria:

* ASA Physical Status IV
* Pregnant and breastfeeding patients
* Pre-existing cardiac arrhythmias
* Patients with neuromuscular diseases
* Patients with psychiatric syndromes under pharmacological treatment
* Patients with chronic use of analgesics
* Patients with a history of drug abuse
* Allergy to one or more drugs used in the protocol
* Refusal to consent

Primary outcomes:
measure: High level of nociception
timeFrame: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
Secondary outcomes:
measure: NOL Index >25
timeFrame: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
measure: NOL Index Peaks
timeFrame: The interval between reaching the appropriate level of sedation (Bispectral Index - BIS between 40 and 60) and the end of the surgical stimulation.
Other outcomes:
measure: Pain at 15th minute
timeFrame: 15th minute post-surgery
measure: Pain at 2nd hour
timeFrame: 2nd hour post-surgery
measure: Analgesic rescue
timeFrame: The interval between the end of the surgical stimulation and the 2nd hour post-surgery.
Locations:
city: Borgomanero
country: Italy
facility: SS. Trinità Hospital
state: Novara
Study officials:
affiliation: ASL Novara
name: Davide Colombo, PhD
role: STUDY_DIRECTOR
References:
citation: Coluzzi F. Intraoperative nociception: "if you can't measure it, you can't manage it". Minerva Anestesiol. 2019 May;85(5):462-464. doi: 10.23736/S0375-9393.19.13612-7. Epub 2019 Feb 13. No abstract available.
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citation: Klein AA, Meek T, Allcock E, Cook TM, Mincher N, Morris C, Nimmo AF, Pandit JJ, Pawa A, Rodney G, Sheraton T, Young P. Recommendations for standards of monitoring during anaesthesia and recovery 2021: Guideline from the Association of Anaesthetists. Anaesthesia. 2021 Sep;76(9):1212-1223. doi: 10.1111/anae.15501. Epub 2021 May 20.
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citation: Meijer F, Honing M, Roor T, Toet S, Calis P, Olofsen E, Martini C, van Velzen M, Aarts L, Niesters M, Boon M, Dahan A. Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):1070-1078. doi: 10.1016/j.bja.2020.07.057. Epub 2020 Sep 17.
citation: Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.