comparison of two drugs Fentanyl and Dexmedetomidine for anaesthetising patients undergoing laparoscopic gynaecological surgery

Comparison of Opioid based and Opioid free TIVA in laparoscopic gynaecological surgery: a randomized control trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015593

Enrollment

Registered

2018-09-05

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: N938- Other specified abnormal uterine and vaginal bleeding

Interventions

Intervention1: Dexmedetomidine : IV Dexmedetomidine loading dose of 1mcg/kg over 10 minutes,followed by infusion of 0.4mcg/kg/min Control Intervention1: Fentanyl: IV Fentanyl loading dose of 2mcg/kg

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA grade I-II patients 2.Patients undergoing laparoscopic gynaecological surgery

Exclusion criteria

Exclusion criteria: 1.Patient refusal to participate 2.Uncontrolled systemic illnesses 3.Patients with BMI >30 4.Patients with cardiac arrhythmias and conduction blocks 5.Patients on beta blockers 6.Patients with documented autonomic dysfunction •Known hypersensitivity to Opioids or Dexmeditomidine •Patients on any drug included in the study for chronic treatment

Design outcomes

Primary

Measure	Time frame
Assessment of recovery profile in both groupsTimepoint: during the period of surgery and till 6 hours postoperatively	—

Secondary

Measure	Time frame
1.Intra-operative Hemodynamic profile 2. serum cortisol levels to assess stress response 3.PONV 4.Patient satisfaction score 5.Time to first rescue analgesic Timepoint: 1.Intraoperative hemodynamic parameters every 30 min for the duration of surgery 2.serum cortisol levels just before induction, at 30 min and at 60 min 3. patient will be followed up for a period of 6hrs postoperatively	—

Countries

India

Contacts

Public ContactDr Karthiga R

All India Institute Of Medical Sciences

drdevalina@gmail.com9868397914

Outcome results

None listed

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