Comparative study between oral melatonin and oral pregabalin on preoperative anxiety and perioperative sedation in surgeries under regional anaesthesia

Not yet recruiting

Conditions: Restlessness and agitation,

Registration Number: CTRI/2019/08/020502

Lead Sponsor: Chettinad Hospital and Research Institute

Brief Summary: **Comparitive study between oral melatonin and oral pregabalin on preoperative anxiety and perioperative sedation in surgeries under sub arachnoid block**

AIM

To compare oral Melatonin(6mg) with oral Pregabalin(300mg) as preoperative anxiolytic, sedative and as a peri-operative analgesic in patients undergoing surgery under sub arachnoid block.

OBJECTIVES

To compare the anxiolysis in both groups

To compare the sedation score between both groups

To compare the psychomotor and cognitive function between both groups

To compare the need for post operative analgesia in both groups

To compare the incidence of any side-effects associated

*MATERIALS & METHODS*

STUDY DESIGN:

Prospective, Randomized, Double blinded study.

SAMPLE SIZE: Kurdi M et al., (2015)

Ghai A et al.,(2012)

Sample size calculation for superiority trial with 80% power, alpha error of 0.05%,95% confidence interval.

Total = 64 Patients

Group I Melatonin~ n = 32

Group II Pregabalin~ n = 32

Patients will be assigned to the respective groups based on a computer generated code

INCLUSION CRITERIA:

American Society of Anaesthesiologists (ASA) grade I-II

Age 18-60 years

BMI<30 kg/m2

Patients scheduled for surgery under subarachnoid block

EXCLUSION CRITERIA:

Pregnant patients

Mentally Impaired patients, those with history of psychiatric disorders, or on any antipsychotic drug intake, sleep disorders and inability to read and write basic alphabets and numbers were excluded from the study

All the patients will undergo preoperative assessment in the preanesthetic assessment clinic. They will be advised fasting of eight hours for solid diet & 2 hours for oral clear fluids prior to surgery. They will also be explained about the visual analog scale (VAS) anxiety score and trail making test(TMT) A and B.

The patient will be assessed for orientation,sedation and anxiety with an oritntation score,the ramsay sedation score and the VAS respectively alongwith the TMT-A and B prior to administering the study drug.The same assessment will be repeated 60 minutes after giving the study drug

The regional anesthesia that will be given is spinal anesthesia in sitting up postion,using a 26G or 27G Quincke needle to administer 3.5ml of plain 0.5% heavy bupivacaine in the L3-L4 space or the L2-L3 space.Vitals will be noted for every 2 minutes for the first 5 minutes,then every 5minutes till 20 minutes post anaesthesia and then evry 10 minutes till the end of surgery. Post surgery we will also note the time when the patient first requests for analgesia.

Adverse effects if any that occur will be reported to the Ethics Committee and appropriate treatment will be given as required.

After decoding of the randomized code, the collected data will be presented as a mean +/- standard deviation, and percentages as appropriate. Categorical variables will be analyzed using Chi-square test and appropriate continuous variables will be tested using Studentâ€™s t-test.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

American Society of Anaesthesiologists(ASA) grade I-II -BMI<30 kg/m2 -patients scheduled for surgery under sub arachnoid block.

Exclusion Criteria

pregnant patients -mentally impaired patients,those with history of psychiatric orders,or on any antipsychotic drug intake,sleep disorders and inability to read and write basic alphabets and numbers were excluded from study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Preoperative Anxiolysis	-Before giving the study drug -1 hour after giving study drug

Secondary Outcome Measures

Name	Time	Method
Sedation Score	-Before giving study drug
Orientation Score	-Before giving study drug
Time Taken for TMT A and B	-Before giving study drug
Time taken for first request for post operative analgesia	Time taken for first request for post operative analgesia

Trial Locations

Locations (1): Chettinad Hospital and Research Institute
🇮🇳
Kancheepuram, TAMIL NADU, India
Chettinad Hospital and Research Institute
🇮🇳Kancheepuram, TAMIL NADU, India
Iris Eapen
Principal investigator
7299589410
iris.eapen@gmail.com