The Impact of Esmolol Administration on Postoperative Recovery (esmolol)
Primary Purpose
Pain, Acute, Pain, Postoperative, Pain, Chronic Post-Surgical
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Esmolol Hydrochloride
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective inguinal hernia repair
Exclusion Criteria:
- body mass index (BMI) >35 kg/m2
- β-blocker administration preoperatively
- 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
- hemodynamic instability
- drug or alcohol abuse
- language or communication barriers
- lack of informed consent
- bilateral inguinal hernia repair
Sites / Locations
- Evangelismos General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
esmolol group
placebo group
Arm Description
loading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h
loading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h
Outcomes
Primary Outcome Measures
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"
Secondary Outcome Measures
Full Information
NCT ID
NCT05567822
First Posted
October 1, 2022
Last Updated
October 25, 2022
Sponsor
Aretaieion University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05567822
Brief Title
The Impact of Esmolol Administration on Postoperative Recovery
Acronym
esmolol
Official Title
The Effect of Intraoperative Esmolol Administration on Postoperative Recovery and Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 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 a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain
Detailed Description
Contemporary anaesthesiology requires the quest of ways to restrict the use of opioids, which aim at the alleviation of severe postoperative and chronic pain. This is not only due to the side effects involved but also to the epidemic dimensions their use entails. Esmolol, an extremely short-acting cardioselective antagonist of β1 adrenergic receptors, is effectively used in order to attenuate the stress response and minimize undesirable perioperative hemodynamic changes. More specifically, esmolol has been used effectively to reduce pain during induction of anesthesia with propofol and treat tachycardia and hypertension during laryngoscopy. However, recent studies also highlight a possible antinociceptive and/or analgesic effect of esmolol. Therefore, The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Postoperative, Pain, Chronic Post-Surgical, Esmolol, Inguinal Hernia Repair, Analgesia, Nociceptive Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
esmolol group
Arm Type
Active Comparator
Arm Description
loading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
loading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h
Intervention Type
Drug
Intervention Name(s)
Esmolol Hydrochloride
Intervention Description
In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively
Primary Outcome Measure Information:
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
Other Pre-specified Outcome Measures:
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
sevoflurane consumption during general anesthesia
Description
the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined
Time Frame
change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours
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 24 hours
Description
patients will be followed for cumulative tramadol consumption for 24 hours postoperatively
Time Frame
24 hours postoperatively
Title
fentanyl requirement during surgery
Description
dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Time Frame
intraoperatively
Title
time to emergence
Description
time from sevoflurane discontinuation to first patient response (eye opening)
Time Frame
up to 2 hours after start of surgery
Title
time to extubation
Description
time from sevoflurane discontinuation to tracheal extubation
Time Frame
up to 2 hours after start of surgery
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
side effects postoperatively
Description
patients will be monitored for side-effects of the administered agents postoperatively
Time Frame
48 hours postoperatively
Title
satisfaction from analgesia
Description
satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
Time Frame
at discharge from Post Anesthesia Care Unit, approximately 1 hour postoperatively
Title
change from baseline in Quality of Recovery (QoR)-15 score after surgery
Description
The QoR-15 is a quality of recovery scale that consists of 15 questions (items),including questions regarding pain (2 items), physical comfort (5 items), self-care ability (2 items), psychological support (2 items) and emotional state (4 items). Every item is scored on a scale of 10, with the lowest total score of 0 and the highest score of 150. The higher the score, the better the recovery quality of the patient
Time Frame
24 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
gastrointestinal recovery after surgery
Description
patients will be questioned regarding the time they first felt enteral sounds and the time they had their first flatus after surgery
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
incidence of chronic pain 1 month after surgery
Description
occurrence of chronic pain at the site of the operation 1 month after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
Time Frame
1 month after surgery
Title
incidence of chronic pain 3 months after surgery
Description
occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
Time Frame
3 months after surgery
Title
duration of nociception level<25 intraoperatively
Description
nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia
Time Frame
intraoperatively
Title
change from baseline in cortisol levels after surgery
Description
blood samples will be collected to measure the variation in cortisol levels from the induction of anesthesia till the arrival of the patient to the Post Anesthesia CAre Unit
Time Frame
during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Title
change from baseline in prolactin levels after surgery
Description
blood samples will be collected to measure the variation in prolactin levels from the induction of anesthesia till the arrival of the patient to the Post Anesthesia CAre Unit
Time Frame
during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Title
change from baseline in lactate levels after surgery
Description
blood samples will be collected to measure the variation in lactate levels from the induction of anesthesia till the arrival of the patient to the Post Anesthesia CAre Unit
Time Frame
during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 inguinal hernia repair
Exclusion Criteria:
body mass index (BMI) >35 kg/m2
β-blocker administration preoperatively
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
hemodynamic instability
drug or alcohol abuse
language or communication barriers
lack of informed consent
bilateral inguinal hernia repair
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kassiani Theodoraki, PhD, DESA
Phone
+306974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vasiliki Samartzi
Email
v.samartzi2@gmail.com
Facility Information:
Facility Name
Evangelismos General Hospital
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, DESA
Phone
6974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name & Degree
Vasiliki Samartzi
Email
v.samartzi2@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31104756
Citation
Egan TD. Are opioids indispensable for general anaesthesia? Br J Anaesth. 2019 Jun;122(6):e127-e135. doi: 10.1016/j.bja.2019.02.018. Epub 2019 Mar 28.
Results Reference
background
PubMed Identifier
34065937
Citation
Salome A, Harkouk H, Fletcher D, Martinez V. Opioid-Free Anesthesia Benefit-Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 May 12;10(10):2069. doi: 10.3390/jcm10102069.
Results Reference
background
PubMed Identifier
30216240
Citation
Bahr MP, Williams BA. Esmolol, Antinociception, and Its Potential Opioid-Sparing Role in Routine Anesthesia Care. Reg Anesth Pain Med. 2018 Nov;43(8):815-818. doi: 10.1097/AAP.0000000000000873.
Results Reference
background
PubMed Identifier
29028742
Citation
Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.
Results Reference
background
PubMed Identifier
28413270
Citation
Watts R, Thiruvenkatarajan V, Calvert M, Newcombe G, van Wijk RM. The effect of perioperative esmolol on early postoperative pain: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):28-39. doi: 10.4103/0970-9185.202182.
Results Reference
background
PubMed Identifier
29670394
Citation
Andresen K, Rosenberg J. Management of chronic pain after hernia repair. J Pain Res. 2018 Apr 5;11:675-681. doi: 10.2147/JPR.S127820. eCollection 2018.
Results Reference
background
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The Impact of Esmolol Administration on Postoperative Recovery
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