TY - JOUR

T1 - Oral melatonin did not reduce anxiety before elective hernia repair

T2 - A randomised, double-blinded, placebo-controlled trial

AU - Holm, Mikkel Andreas

AU - Gram-Hanssen, Anders

AU - Madsen, Bennedikte Kollerup

AU - Zetner, Dennis Bregner

AU - Rosenberg, Jacob

N1 - Funding Information: A.P. Moller Foundation (reg.no.: 19-L-0021). Foundation Juchum (reg.no: 34599). The funders had no influence on design, data analyses or reporting. Publisher Copyright: © 2022 Acta Anaesthesiologica Scandinavica Foundation.

PY - 2022

Y1 - 2022

N2 - Background: Preoperative anxiety is a common issue in surgery. Preoperative anxiety may lead to increased mortality, pain and dissatisfaction with surgery. Melatonin is a drug with only mild adverse effects and has previously been shown to reduce anxiety and pain in the perioperative setting. The aim of study was to investigate the anxiolytic effect of melatonin in the preoperative setting. Methods: This study was a randomised, double-blinded, placebo-controlled clinical trial. Included patients were allocated in the ratio 1:1 to either the placebo group or the melatonin group. Patients received 10 mg melatonin or placebo the evening before surgery, 2 h before surgery, immediately after surgery and the evening after surgery. Preoperative anxiety was examined 1 h before surgery, using the State Trait Anxiety Inventory (STAI) questionnaire, along with a Visual Analogue Scale (VAS) of anxiety. Furthermore, participants filled out a sleep log each morning, where we examined sleep quality, comfort and drowsiness. Results: Sixteen patients received placebo treatment and 17 patients received melatonin. Median state anxiety on the STAI scale at baseline was 27 (interquartile range [IQR] 22–34) for the melatonin group and 27 (IQR 23–31) for the placebo group. In the primary outcome of preoperative anxiety 1 h before surgery, the median state anxiety on the STAI scale was 27 (IQR 24–34) for the melatonin group and 28 (24–33) for the placebo group, p =.814. VAS anxiety was median 7 (0–28) for the melatonin group and median 7 (1–13) for the placebo group, p =.813. Furthermore, there were no statistically significant differences between the two groups in the secondary outcomes of sleep quality and consumption of analgesics. Conclusion: Melatonin did not reduce preoperative anxiety in patients undergoing hernia repair. Preoperative anxiety levels were low, which limits the generalisability of our findings.

AB - Background: Preoperative anxiety is a common issue in surgery. Preoperative anxiety may lead to increased mortality, pain and dissatisfaction with surgery. Melatonin is a drug with only mild adverse effects and has previously been shown to reduce anxiety and pain in the perioperative setting. The aim of study was to investigate the anxiolytic effect of melatonin in the preoperative setting. Methods: This study was a randomised, double-blinded, placebo-controlled clinical trial. Included patients were allocated in the ratio 1:1 to either the placebo group or the melatonin group. Patients received 10 mg melatonin or placebo the evening before surgery, 2 h before surgery, immediately after surgery and the evening after surgery. Preoperative anxiety was examined 1 h before surgery, using the State Trait Anxiety Inventory (STAI) questionnaire, along with a Visual Analogue Scale (VAS) of anxiety. Furthermore, participants filled out a sleep log each morning, where we examined sleep quality, comfort and drowsiness. Results: Sixteen patients received placebo treatment and 17 patients received melatonin. Median state anxiety on the STAI scale at baseline was 27 (interquartile range [IQR] 22–34) for the melatonin group and 27 (IQR 23–31) for the placebo group. In the primary outcome of preoperative anxiety 1 h before surgery, the median state anxiety on the STAI scale was 27 (IQR 24–34) for the melatonin group and 28 (24–33) for the placebo group, p =.814. VAS anxiety was median 7 (0–28) for the melatonin group and median 7 (1–13) for the placebo group, p =.813. Furthermore, there were no statistically significant differences between the two groups in the secondary outcomes of sleep quality and consumption of analgesics. Conclusion: Melatonin did not reduce preoperative anxiety in patients undergoing hernia repair. Preoperative anxiety levels were low, which limits the generalisability of our findings.

KW - anxiety

KW - clinical trial

KW - inguinal hernia

KW - melatonin

KW - preoperative

KW - randomised

KW - surgery

U2 - 10.1111/aas.14128

DO - 10.1111/aas.14128

M3 - Journal article

C2 - 36106858

AN - SCOPUS:85135947728

VL - 66

SP - 1091

EP - 1098

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 9

ER -