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The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin 5 mg
Sugar Coated Tablets
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postoperative Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients undergoing nephrectomy under general anesthesia aged from 20 to 60 years.
  • ASA 1 or 2.
  • BMI 25 to 30

Exclusion Criteria:

  • Patients with uncontrolled hypertension.
  • Patients presenting with (IHD, significant arrhythmias, heart failure).
  • Allergy to melatonin.
  • History of epileptic seizures, psychoactive medications, neurological disorders or trauma.

Sites / Locations

  • Amany Hassan Saleh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

melatonin group

control group

Arm Description

Melatonin group (group M )will receive melatonin as a premedication 1 hour before surgery in a dose of 5 mg

15 patients will be enrolled for open nephrectomy will receive sugar-coated tablets. Control group(group C)

Outcomes

Primary Outcome Measures

Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60
Inhaled Isoflurane requirement (volume %) will be titrated to maintain state entropy (SE) and response entropy (RE) readings 40-60 measured using GE carestation 650-crescent pulse anaesthesia machine(6).

Secondary Outcome Measures

Total morphine consumption over 24 hours postoperative
Total intraoperative fentanyl consumption
The sum of fentanyl top up doses will be recorded

Full Information

First Posted
July 2, 2021
Last Updated
July 19, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04959825
Brief Title
The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy
Official Title
Effect of Preoperative Melatonin in Inhaled Anesthetic Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
April 10, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Melatonin is a hormone that the pineal gland in the brain produces. Melatonin fulfills many functions in the body but it is mostly known for maintaining a circadian rhythm that is governed by the central circadian pacemaker (biological clock) in the suprachiasmatic nuclei in the hypothalamus. Melatonin works by attaching to receptors or nerve endings in the suprachiasmatic nucleus (SCN) in the hypothalamus. It binds to melatonin receptor 1 and melatonin receptor 2, commonly referred to as MT1 and MT2. People can take it as a natural or synthetic supplement to promote restful sleep. Melatonin showed promise for preventing shifts in sleep and wake times in people with jetlag and improving sleep in people with insomnia. It can also be used for headaches, cancer, and Alzheimer's disease. Melatonin can be used as an analgesic, sedative, and hypnotic drug that can distinguish it as an attractive alternative premedicant
Detailed Description
A study that was done before in J Anaesth by Borazan H et al revealed that postoperative pain score in patients undergoing radical prostatectomy who received melatonin one hour before surgery as a premedication was significantly lower than the control group with a significant P-value( less than 0.05). The entropy is indicated for adult and pediatric patients older than 2 years intraoperatively for monitoring the electric state of the brain. In adult patients, state entropy and response entropy can be used as an aid in monitoring the effects of certain anaesthetic agents which will help the user to titrate the anaesthetic agent according to the individual needs of each patient. Furthermore, the use of entropy parameters may be associated with a reduction of anaesthetic use and faster emergence of anaesthesia. The entropy measurement is to be used as an adjunct to other physiological parameters. To the best of investigators knowledge, there is no study that examined the effect of melatonin on inhaled isoflurane requirements intraoperatively. So, in this study, the effect of melatonin will be assessed on intraoperative inhaled isoflurane requirements in patients undergoing open nephrectomy under general anaesthesia by using entropy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients will be allocated to the study groups using a computer-generated random list, and the group assignments will be sealed in sequentially numbered opaque envelopes that will be opened before induction of anesthesia. The data collector will be blinded to the group assignment and to the monitoring anesthetist, and the person who will give the drug will not bethe data collector.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
melatonin group
Arm Type
Active Comparator
Arm Description
Melatonin group (group M )will receive melatonin as a premedication 1 hour before surgery in a dose of 5 mg
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
15 patients will be enrolled for open nephrectomy will receive sugar-coated tablets. Control group(group C)
Intervention Type
Drug
Intervention Name(s)
Melatonin 5 mg
Intervention Description
study the effect of preoperative oral melatonin 5mg on isoflurane consumption and postoperative pain
Intervention Type
Drug
Intervention Name(s)
Sugar Coated Tablets
Intervention Description
the control group patients will receive placebo tablets one hour before induction of anesthesia
Primary Outcome Measure Information:
Title
Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60
Description
Inhaled Isoflurane requirement (volume %) will be titrated to maintain state entropy (SE) and response entropy (RE) readings 40-60 measured using GE carestation 650-crescent pulse anaesthesia machine(6).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Total morphine consumption over 24 hours postoperative
Time Frame
24 hours
Title
Total intraoperative fentanyl consumption
Description
The sum of fentanyl top up doses will be recorded
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing nephrectomy under general anesthesia aged from 20 to 60 years. ASA 1 or 2. BMI 25 to 30 Exclusion Criteria: Patients with uncontrolled hypertension. Patients presenting with (IHD, significant arrhythmias, heart failure). Allergy to melatonin. History of epileptic seizures, psychoactive medications, neurological disorders or trauma.
Facility Information:
Facility Name
Amany Hassan Saleh
City
Giza
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy

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