The Impact of Esmolol Administration on Postoperative Recovery
esmolol
The Effect of Intraoperative Esmolol Administration on Postoperative Recovery and Chronic Pain
1 other identifier
interventional
70
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedOctober 27, 2022
October 1, 2022
2 years
October 1, 2022
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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"
3 hours postoperatively
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"
6 hours postoperatively
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"
24 hours postoperatively
Other Outcomes (27)
pain score on arrival to Post-Anesthesia Care Unit (PACU)
immediately postoperatively
pain score at discharge from Post-Anesthesia Care Unit (PACU)
at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]
sevoflurane consumption during general anesthesia
change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours
- +24 more other outcomes
Study Arms (2)
esmolol group
ACTIVE COMPARATORloading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h
placebo group
PLACEBO COMPARATORloading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h
Interventions
In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively
In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively
Eligibility Criteria
You may qualify if:
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective inguinal hernia repair
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evangelismos General Hospital
Athens, 10676, Greece
Related Publications (6)
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.
PMID: 31104756BACKGROUNDSalome 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.
PMID: 34065937BACKGROUNDBahr 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.
PMID: 30216240BACKGROUNDGelineau 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.
PMID: 29028742BACKGROUNDWatts 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.
PMID: 28413270BACKGROUNDAndresen 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.
PMID: 29670394BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
October 1, 2022
First Posted
October 5, 2022
Study Start
October 1, 2022
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
October 27, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share