Effect of Melatonin on Sleep in the Perioperative Period after Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.

STUDY OBJECTIVES: To investigate whether administration of an oral dose of 6 mg melatonin before bedtime perioperatively in breast cancer surgery could change sleep outcomes measured by actigraphy. METHODS: This paper reports secondary outcomes from a double-blind, placebo-controlled, randomized clinical trial where patients received 6 mg melatonin (n = 27) or placebo (n = 21) approximately 60 minutes before bedtime 3 nights preoperatively until at least one week postoperatively. Participants were monitored in the entire period with actigraphy, and were instructed to complete visual analogue scale (VAS) for sleep, and the Karolinska Sleepiness Scale (KSS) each morning. RESULTS: Administration of 6 mg oral melatonin approximately 1 hour before bedtime resulted in significantly increased sleep efficiency and reduced wake after sleep onset for the entire 2-week postoperative period. No other significant differences for actigraphy determined sleep outcomes or subjective outcome parameters in the perioperative period were found between the groups. Overall, the patients sleep outcomes were within normal ranges and no participants had pathological sleep disturbances. CONCLUSIONS: Melatonin significantly changed sleep efficiency and wake after sleep onset after surgery, but had no effects on other objective sleep outcomes or on subjective sleep quality (VAS and KSS).

New and chronic use of hypnotics after diagnosis with early breast cancer. A retrospective cohort study.

BACKGROUND: To determine use and investigate factors associated with use of hypnotics the first year after a diagnosis with breast cancer. MATERIAL AND METHODS: A retrospective registry based cohort study linking clinical data from the Danish Breast Cancer Group with the National Prescription Drug Database and other health and administrative registries. We included 26 082 women diagnosed with early breast cancer as first time primary cancer during 1996-2006. Use of hypnotics was measured as redeemed prescriptions in the first year after diagnosis of early breast cancer. Prior use of hypnotics was defined as one or more prescriptions of hypnotics 13 months to 1 month before diagnosis, and chronic use was defined as four or more prescriptions. Hazard ratios (HRs) for clinical variables, treatment-related factors and sociodemographic factors were calculated. RESULTS: Among women with no prior history of hypnotic use, 17% became new users with 4% on a chronic level. Among prior users, 82% continued their use with one or more prescriptions of hypnotics and 15% increased their use to a chronic level. Significantly increased hazard ratios for use of hypnotics were seen with increasing age [age 50-59 years: HR 1.43 (95% CI 1.31-1.57), age 60-69: HR 1.57 (95% CI 1.44-1.71)], increasing number of tumor positive lymph nodes [1-3 lymph nodes: HR 1.12 (95% CI 1.05-1.09), 4-9 lymph nodes: HR 1.11 (95% CI 1.02-1.29)], chemotherapy [HR 1.25 (95% CI 1.12-1.39)], somatic comorbidity [HR 1.31 (95% CI 1.21-1.42)] and use of antidepressants the year before breast cancer diagnosis [HR 1.97 (95% CI 1.85-2.10)]. CONCLUSION: This study detected a group of patients at great risk for initiating and increasing use of hypnotics and preventive and prophylactic mechanism should be investigated and initiated when this group of patients is seen in the clinical setting.

Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.

Background. Sleep disturbances and cognitive dysfunction are common in patients with breast cancer. Disturbed sleep leads to poor cognitive performance and exogenous melatonin may improve sleep and attenuate cognitive dysfunction. We hypothesized that melatonin would improve sleep and cognitive function after surgery. Methods. This study reports secondary endpoints from a randomized, double-blind, placebo-controlled trial. Women, 30-75 years, were randomized to 6mg oral melatonin/placebo for 3 months. We assessed postoperative cognitive dysfunction (POCD) with a neuropsychological test battery, sleep with a diary, and sleep quality with VAS. Results. 54 patients were randomized to melatonin (n = 28) or placebo (n = 26); 11 withdrew (10 placebo, 1 melatonin, P = 0.002). The incidence of POCD was 0% (0/20) [95% CI 0.0%; 16.8%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 2 weeks postoperatively (P = 1.00) and 6.3% (1/16) [95% CI 0.0%; 30.2%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 12 weeks postoperatively (P = 0.38). Sleep efficiency was significantly greater in the melatonin group; mean difference was 4.28% [95% CI 0.57; 7.82] (P = 0.02). The total sleep period was significantly longer in the melatonin group; mean difference was 37.0 min [95% CI 3.6; 69.7] (P = 0.03). Conclusion. Melatonin increased sleep efficiency and total sleep time but did not affect cognitive function. The dropout rate was significantly lower in the melatonin group. This trial is registered with Clinicaltrials.gov NCT01355523.

No increased risk of perforation during colonoscopy in patients undergoing Nurse Administered Propofol Sedation.

OBJECTIVE: Nurse Administered Propofol Sedation (NAPS) contributes to a deeper sedation of the patients, making them unable to respond to pain and an increased incidence of perforations has been speculated. The objective of this study was to evaluate the risk of perforations during colonoscopies performed with either NAPS or conventional sedation regimes. MATERIAL AND METHODS: Data were retrospectively retracted from medical journals from 1 January 2007 to 31 December 2011. All journals were examined and cross-referenced to reveal any perforations. We analyzed all colonoscopies in regard to nature of the procedure (diagnostic vs therapeutic), experience of the endoscopist and ASA-classification of the patients. RESULTS: A total of 6371 colonoscopies were performed, of which 3155 were performed under propofol sedation. There were 16 perforations (0.25%); 10 of these performed during NAPS and 6 during conventional colonoscopy (p = 0.454, OR: 1.7 (95% CI: 0.6-5.7)). There were 4874 diagnostic and 1497 therapeutic colonoscopies, with a majority of the perforations (94%) occurring during a diagnostic procedure (p = 0.389). No statistically difference was found in the incidence of perforations caused by an experienced or less experienced endoscopist (p = 0.589). CONCLUSION: The risk of colonic perforations during colonoscopy was not found to be significantly higher in patients undergoing NAPS compared to patients undergoing conventional sedation, although a tendency may exist. Furthermore, we found no correlation to neither experience of the endoscopist, nature of the procedure nor sex of the patients. Larger and prospective studies are needed to further evaluate on this subject.