Evaluation of the effect of melatonin(sleep-wake regulating hormone) premedication on preoperative anxiety, propofol(general anaesthetic) induction dosage, perioperative haemodynamics(blood pressure,heart rate) and quality of recovery : An exploratory study

Evaluation of the effect of melatonin premedication on preoperative anxiety, propofol induction dosage, perioperative haemodynamics and quality of recovery : An exploratory study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036209

Enrollment

100

Registered

2021-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N879- Dysplasia of cervix uteri, unspecified Health Condition 2: N809- Endometriosis, unspecified Health Condition 3: N819- Female genital prolapse, unspecified Health Condition 4: N979- Female infertility, unspecified Health Condition 5: N739- Female pelvic inflammatory disease, unspecified Health Condition 6: N74- Female pelvic inflammatory disorders in diseases classified elsewhere Health Condition 7: N72- Inflammatory disease of cervix uteri Health Condition 8: N719- Infl

Interventions

Intervention1: Tablet Melatonin 5 mg: Group1: Tab Melatonin 5mg night before surgery and 2 hour before surgery with sips of water Control Intervention1: Tablet Alprazolam 0.25mg: Group 2: Tab Alprazol

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA-I, I 2. Female Patient 3. 18 to 65 years of age undergoing elective laparoscopic gynaecological surgery

Exclusion criteria

Exclusion criteria: 1. patient not willing to participate 2. significant cardiac, hepatic renal dysfunction 3. allergy to study drugs 4. Patient with a history of chronic use of sedatives or analgesics especially opioids and gabapentinoids 5. patients requiring post operative ventilatory support

Design outcomes

Primary

Measure	Time frame
1.Preoperative anxiety and sedation 2.Quality of recovery (QoR 15 score) Timepoint: From time in preoperative room till 24hour of surgery	—

Secondary

Measure	Time frame
1. Induction dosage of propofol 2.Perioperative haemodynamic effectsTimepoint: From start of induction till 24 hour after surgery	—

Countries

India

Contacts

Public ContactManasmita Dalai

AIIMS Rishikesh

docagrawal72@yahoo.com9761712630

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026