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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05567822
Other study ID # 89/24-03-2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date October 1, 2024

Study information

Verified date October 2022
Source Aretaieion University Hospital
Contact Kassiani Theodoraki, PhD, DESA
Phone +306974634162
Email ktheodoraki@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 - ß-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

Study Design


Intervention

Drug:
Esmolol Hydrochloride
In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively
normal saline
In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively

Locations

Country Name City State
Greece Evangelismos General Hospital Athens

Sponsors (1)

Lead Sponsor Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (6)

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. Review. — View 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. Review. — View 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. Review. — View 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. — View Citation

Salomé 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). pii: 2069. doi: 10.3390/jcm10102069. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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" immediately postoperatively
Other 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" at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]
Other sevoflurane consumption during general anesthesia the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours
Other time to first request for analgesia the time for the first patient request for analgesia will be noted during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Other morphine consumption in Post-Anesthesia Care Unit (PACU) mg of morphine requested during patient PACU stay immediately postoperatively
Other tramadol consumption in the first 24 hours patients will be followed for cumulative tramadol consumption for 24 hours postoperatively 24 hours postoperatively
Other fentanyl requirement during surgery dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value intraoperatively
Other time to emergence time from sevoflurane discontinuation to first patient response (eye opening) up to 2 hours after start of surgery
Other time to extubation time from sevoflurane discontinuation to tracheal extubation up to 2 hours after start of surgery
Other Post Anesthesia Care Unit (PACU) duration of stay duration of patient stay at PACU immediately postoperatively
Other 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 immediately postoperatively
Other 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 at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Other side effects postoperatively patients will be monitored for side-effects of the administered agents postoperatively 48 hours postoperatively
Other satisfaction from analgesia satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction at discharge from Post Anesthesia Care Unit, approximately 1 hour postoperatively
Other change from baseline in Quality of Recovery (QoR)-15 score after surgery 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 24 hours postoperatively
Other 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) 24 hours postoperatively
Other first mobilization after surgery patients will be questioned regarding the time at which they mobilized after surgery 24 hours postoperatively
Other gastrointestinal recovery after surgery patients will be questioned regarding the time they first felt enteral sounds and the time they had their first flatus after surgery 24 hours postoperatively
Other first fluid intake patients will be questioned regarding the time they had their first fluid intake 24 hours postoperatively
Other first solid intake patients will be questioned regarding the time they had their first solid intake 24 hours postoperatively
Other hospitalization time duration of hospital stay after surgery in hours 96 hours postoperatively
Other incidence of chronic pain 1 month after surgery 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 1 month after surgery
Other incidence of chronic pain 3 months after surgery 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 3 months after surgery
Other duration of nociception level<25 intraoperatively nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia intraoperatively
Other change from baseline in cortisol levels after surgery 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 during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Other change from baseline in prolactin levels after surgery 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 during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Other change from baseline in lactate levels after surgery 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 during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Primary 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
Primary 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
Primary 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
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