Melatonin vs Gabapentin for Post Trauma Surgery

• Sponsor: All India Institute of Medical Sciences, New Delhi (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05699876
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.5
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

This project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. Gabapentin has analgesic as well as sedative properties. Melatonin, a hormone has been extensively used in intensive care units and has found to improve the sleep cycle and reduce pain. It is now being explored as a preoperative medication.

Condition or Disease	Intervention/Treatment	Phase
Anxiety, Preoperarative	Drug: Melatonin 6 MG; Drug: Gabapentin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of Melatonin and Gabapentin as Premedication for Patients Undergoing Surgery Following Trauma
• Anticipated Study Start Date: Jan 15, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin	Drug: Melatonin 6 MG; melatonin will be administered orally preoperatively as premedication
Active Comparator: Gabapentin	Drug: Gabapentin; melatonin will be administered orally preoperatively as premedication

Outcome Measures

Primary Outcome Measures

1. preoperative anxiety [30 minutes after drug administration]

   evaluate the difference in the preoperative anxiety score(Numerical Rating Scale ) before and after drug administration

Secondary Outcome Measures

1. inflammatory markers [before and 30 minutes after drug administrartion]

   o The serum cortisol and IL6 levels (biochemical markers of stress) intraoperatively and postoperatively

2. Sedation score [before and 30 minutes after drug administrartion]

   Sedation score based on Observer Assessment of Alertness/Sedation Scale (OAA/S) before and after drug administration

3. post operative analgesia [24 hours postoperative]

   o Total fentanyl consumption 24 hours post-surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria: Patients will be recruited if they satisfy the following inclusion criteria:

• Age 18-65 years,

• ASA score I-II,

• Scheduled either for non-emergency surgery after trauma and

• Presumptive duration of operation not exceeding 3 hours.

Exclusion criteria: The following patients will be excluded from the study:

• Patients for emergency surgeries

• Surgeries taking place after 1pm (to account for diurnal variation in cortisol levels)

• Patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication

• Patients who have come for a repeat surgery and have already been included once in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aiims	New Delhi	Delhi	India	110029

Sponsors and Collaborators

• All India Institute of Medical Sciences, New Delhi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kelika Prakash, Assistant Professor, All India Institute of Medical Sciences, New Delhi
• ClinicalTrials.gov Identifier: NCT05699876
• Other Study ID Numbers: AIIMS Delhi
• First Posted: Jan 26, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kelika Prakash, Assistant Professor, All India Institute of Medical Sciences, New Delhi: melatonin; gabapentin; preoperative anxiety
• Additional relevant MeSH terms: Gabapentin; Melatonin

Study Results

No Results Posted as of Jan 26, 2023