Anxiolytic and Analgesic Effects of Melatonin

NCT02386319 | Completed Phase 3 Results DMC

• 1 other identifier: Melatonin1234
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study's main objective is to investigate melatonin's anxiolytic and sleep-regulating effects in patients undergoing surgery. Moreover, the investigators intend to investigate the pharmacokinetic parameters of melatonin in this patient population.

Conditions

Anxiety

Keywords

Melatonin; Surgery; Pharmacokinetic; Anxiolytic

Outcome Measures

Primary Outcomes (1)

• Preoperative Anxiety

  The "State" scale of the State-Trait Anxiety Inventory (STAI). Construct: Current level of anxiety. Scale range: 20-40 (higher scores indicate higher level of current anxiety) Scores are calculated according to the STAI scoring manual by adding point from each item (possible point for each item is 1-4).

  60 minutes preoperative

Secondary Outcomes (9)

• Postoperative Anxiety

  at the preoperative interview, 60 minutes prior to surgery and 4 hours postoperatively.

• Pre- and Postoperative Anxiety

  at the preoperative interview, 60 minutes prior to surgery, 1 and 4 hours postoperatively.

• Intraoperative Requirement of Remifentanil

  intraopeative

• Intraoperative Requirement of Propofol

  intraoperative

• Use of Rescue-opioids in the PACU

  0-24 hours postoperative

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

Melatonin 10 mg, gelatin capsules. Pharmacokinetic study: 10 mg x 2. In the morning before surgery and in the evening after surgery. Anxiolytic and analgesic study: 10 mg x 4. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Gelatin capsules. Anxiolytic and analgesic study. Evening the day before surgery, the morning before surgery, immediately after surgery and the evening after surgery.

Drug: Placebo

Interventions

Melatonin DRUG

Gelatin capsules

Melatonin

Placebo DRUG

Placebo capsules

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are candidates for breast surgery.
• BMI between 18 and 30
• Visible veins in the elbow region
• Fertile women use anti-contraception and have performed a negative pregnancy test

You may not qualify if:

• Patients, who use daily opioids, benzodiazepines or melatonin
• Patients diagnosed with a psychiatric disorder (defined as in medical treatment)
• Patients with severe physical disease (ASA 3-4)
• Patients with previous or ongoing alcohol or drug abuse
• Patients with liver disease (defined as in medical treatment)
• Patients diagnosed sleep disturbances
• Patients who are unable to cooperate according to the protocol
• Patients with allergy to melatonin
• \- Male patients who are candidates for inguinal or umbilical hernia reapir
• Patients, who use daily opioids, benzodiazepines or melatonin
• Patients diagnosed with a psychiatric disorder (defined as in medical treatment)
• Patients with severe physical disease (ASA 3-4)
• Patients with previous or ongoing alcohol or drug abuse
• Patients with liver disease (defined as in medical treatment)
• Patients diagnosed sleep disturbances

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

• Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3.

  PMID: 33319916 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Anders Gram-Hanssen
• Organization: Herlev Hospital

anders.gram-hanssen@regionh.dk

004526225318

Study Officials

• Dennis B Zetner, MD.

  Herlev Hospital, Herlev Ringvej 75, Herlev, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Ph d fellow

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 11, 2015
• Study Start: August 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 2, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-08

Locations

DK (1)