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Opioid-free Anesthesia in Thyroidectomies

Primary Purpose

Pain, Post Operative, Pain, Acute, Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
dexmedetomidine-ketamine-lidocaine (DKL)
remifentanil infusion
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Post Operative

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients
  • American Society of Anesthesiologists (ASA) classification I-II
  • elective thyroidectomy

Exclusion Criteria:

  • body mass index (BMI) >35 kg/m2
  • contraindications to local anesthetic administration
  • systematic use of analgesic agents preoperatively
  • chronic pain syndromes preoperatively
  • neurological or psychiatric disease on treatment
  • pregnancy
  • severe hepatic or renal disease
  • history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
  • bradycardia(<55 beats/minute)
  • drug or alcohol abuse
  • language or communication barriers lack of informed consent

Sites / Locations

  • General Hospital of Athens, "Georgios Gennimatas"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexmedetomidine-ketamine-lidocaine (DKL) group

remifentanil (control) group

Arm Description

combination of dexmedetomidine-ketamine-lidocaine in one syringe

remifentanil infusion (TCI Minto protocol)

Outcomes

Primary Outcome Measures

change from baseline in Quality of Recovery (QoR)-40 score after surgery
The QoR-40 is used to measure functional recovery and has been validated in patients undergoing general surgical procedures. Five general quality-of-recovery dimensions are measured within the QoR-40: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is graded on a five-point Likert scale, and the global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
pain score on arrival to Post-Anesthesia Care Unit (PACU)
pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score at discharge from Post-Anesthesia Care Unit (PACU)
pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 3 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 6 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 24 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Nociception Level
Nociception Level as measured via the NOL (Nociception Level) index, whose values vary from 0 to 100 (100 represents the maximum level of nociception and 0 represents total absence of nociception). The aim of the current study will be to record percentage of operative time during which NOL levels will be <25

Secondary Outcome Measures

remifentanil requirement during anesthesia
rescue remifentanil required intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Post Anesthesia Care Unit (PACU) duration of stay
duration of patient stay at PACU
sedation on arrival to Post-Anesthesia Care Unit
sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
sedation at discharge from Post-Anesthesia Care (PACU) Unit
sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
time to first request for analgesia
the time for the first patient request for analgesia will be noted
morphine consumption in Post-Anesthesia Care Unit (PACU
mg of morphine requested during patient PACU stay
tramadol consumption in the first 48 hours
patients will be followed for cumulative tramadol consumption for 48 hours postoperatively
sleep quality
subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality)
first mobilization after surgery
patients will be questioned regarding the time at which they mobilized after surgery
satisfaction from postoperative analgesia
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
first fluid intake
patients will be questioned regarding the time they had their first fluid intake
first solid intake
patients will be questioned regarding the time they had their first solid intake
hospitalization time
duration of hospital stay after surgery in hours
side effects intraoperatively
patients will be monitored for side-effects of the administered agents intraoperatively
side effects postoperatively
patients will be monitored for side-effects of the administered agents postoperatively

Full Information

First Posted
February 8, 2022
Last Updated
April 24, 2023
Sponsor
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05243940
Brief Title
Opioid-free Anesthesia in Thyroidectomies
Official Title
Recovery Parameters and Nociception Levels in Opioid-free Versus Opioid Based Anesthesia for Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective thyroidectomies. Recovery parameters and nociception levels throughout the operation will be evaluated
Detailed Description
In the usual anesthetic practice opioids are often administered in the perioperative period for intraoperative analgesia to control the nociceptive pathway of pain and post-surgical pain management. However, in recent years, opioid Free Anesthesia (OFA) has become increasingly popular, in which opioid administration is avoided intraoperatively and minimized or avoided in the postoperative period. Opioid-free anesthesia (OFA) has been shown to decrease postoperative complications associated with opioids, include sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression. Therefore, the investigators aim to perform this study to determine a goal-directed approach, which targets adequate antinociception (e.g., by measuring nociceptive/antinociceptive balance) that could reduce the negative effects of excessive drug infusion, prevent postoperative pain and improve patient outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Operative, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Pain, Nociceptive, Ketamine, Dexmedetomidine, Lidocaine, Fentanyl, Analgesia, Analgesics, Analgesics Non-narcotic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine-ketamine-lidocaine (DKL) group
Arm Type
Active Comparator
Arm Description
combination of dexmedetomidine-ketamine-lidocaine in one syringe
Arm Title
remifentanil (control) group
Arm Type
Active Comparator
Arm Description
remifentanil infusion (TCI Minto protocol)
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine-ketamine-lidocaine (DKL)
Intervention Description
patients will be administered 0.25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1 mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution.
Intervention Type
Drug
Intervention Name(s)
remifentanil infusion
Intervention Description
remifentanil infusion under the Minto model (target controlled infusion-TCI aiming at 4ng/ml blood concentration
Primary Outcome Measure Information:
Title
change from baseline in Quality of Recovery (QoR)-40 score after surgery
Description
The QoR-40 is used to measure functional recovery and has been validated in patients undergoing general surgical procedures. Five general quality-of-recovery dimensions are measured within the QoR-40: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is graded on a five-point Likert scale, and the global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
Time Frame
24 hours postoperatively
Title
pain score on arrival to Post-Anesthesia Care Unit (PACU)
Description
pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame
immediately postoperatively
Title
pain score at discharge from Post-Anesthesia Care Unit (PACU)
Description
pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame
at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Title
pain score 3 hours postoperatively
Description
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame
3 hours postoperatively
Title
pain score 6 hours postoperatively
Description
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame
6 hours postoperatively
Title
pain score 24 hours postoperatively
Description
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame
24 hours postoperatively
Title
Nociception Level
Description
Nociception Level as measured via the NOL (Nociception Level) index, whose values vary from 0 to 100 (100 represents the maximum level of nociception and 0 represents total absence of nociception). The aim of the current study will be to record percentage of operative time during which NOL levels will be <25
Time Frame
intraoperatively
Secondary Outcome Measure Information:
Title
remifentanil requirement during anesthesia
Description
rescue remifentanil required intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Time Frame
intraoperatively
Title
Post Anesthesia Care Unit (PACU) duration of stay
Description
duration of patient stay at PACU
Time Frame
immediately postoperatively
Title
sedation on arrival to Post-Anesthesia Care Unit
Description
sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
Time Frame
immediately postoperatively
Title
sedation at discharge from Post-Anesthesia Care (PACU) Unit
Description
sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
Time Frame
at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Title
time to first request for analgesia
Description
the time for the first patient request for analgesia will be noted
Time Frame
during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Title
morphine consumption in Post-Anesthesia Care Unit (PACU
Description
mg of morphine requested during patient PACU stay
Time Frame
immediately postoperatively
Title
tramadol consumption in the first 48 hours
Description
patients will be followed for cumulative tramadol consumption for 48 hours postoperatively
Time Frame
48 hours postoperatively
Title
sleep quality
Description
subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality)
Time Frame
24 hours postoperatively
Title
first mobilization after surgery
Description
patients will be questioned regarding the time at which they mobilized after surgery
Time Frame
24 hours postoperatively
Title
satisfaction from postoperative analgesia
Description
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
Time Frame
24 hours postoperatively
Title
first fluid intake
Description
patients will be questioned regarding the time they had their first fluid intake
Time Frame
24 hours postoperatively
Title
first solid intake
Description
patients will be questioned regarding the time they had their first solid intake
Time Frame
24 hours postoperatively
Title
hospitalization time
Description
duration of hospital stay after surgery in hours
Time Frame
96 hours postoperatively
Title
side effects intraoperatively
Description
patients will be monitored for side-effects of the administered agents intraoperatively
Time Frame
intraoperatively
Title
side effects postoperatively
Description
patients will be monitored for side-effects of the administered agents postoperatively
Time Frame
48 hours postoperatively
Other Pre-specified Outcome Measures:
Title
time to emergence
Description
time from sevoflurane discontinuation to first patient response (eye opening)
Time Frame
up to 2-3 hours after start of surgery]
Title
time to extubation
Description
time from sevoflurane discontinuation to tracheal extubation
Time Frame
up to 2-3 hours after start of surgery]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients American Society of Anesthesiologists (ASA) classification I-II elective thyroidectomy Exclusion Criteria: body mass index (BMI) >35 kg/m2 contraindications to local anesthetic administration systematic use of analgesic agents preoperatively chronic pain syndromes preoperatively neurological or psychiatric disease on treatment pregnancy severe hepatic or renal disease history of cardiovascular diseases/ arrhythmias/ conduction abnormalities bradycardia(<55 beats/minute) drug or alcohol abuse language or communication barriers lack of informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KASSIANI THEODORAKI, MD, PhD, DESA
Phone
+306974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rammi Devadze, MD
Phone
+306949535388
Email
gurdevadze@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KASSIANI THEODORAKI, MD, PhD, DESA
Organizational Affiliation
Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Athens, "Georgios Gennimatas"
City
Athens
State/Province
Attiki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rammi Devadze, MD
Phone
+306949535388
Email
gurdevadze@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonia Dimakopoulou, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24829420
Citation
Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
Results Reference
background
PubMed Identifier
29775728
Citation
Forget P. Opioid-free anaesthesia. Why and how? A contextual analysis. Anaesth Crit Care Pain Med. 2019 Apr;38(2):169-172. doi: 10.1016/j.accpm.2018.05.002. Epub 2018 Sep 13.
Results Reference
background
PubMed Identifier
20042674
Citation
Martin JL, Koodie L, Krishnan AG, Charboneau R, Barke RA, Roy S. Chronic morphine administration delays wound healing by inhibiting immune cell recruitment to the wound site. Am J Pathol. 2010 Feb;176(2):786-99. doi: 10.2353/ajpath.2010.090457. Epub 2009 Dec 30.
Results Reference
background
PubMed Identifier
24554545
Citation
Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
Results Reference
background
PubMed Identifier
33712080
Citation
Song JY, Choi H, Chae M, Ko J, Moon YE. The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial. Trials. 2021 Mar 12;22(1):207. doi: 10.1186/s13063-021-05166-z.
Results Reference
background
PubMed Identifier
31047645
Citation
Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
Results Reference
background
PubMed Identifier
30802933
Citation
Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
Results Reference
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Opioid-free Anesthesia in Thyroidectomies

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