A study to compare different parameters following opioid (medications that decrease pain) free technique versus standard technique of general anesthesia (using opioids) for removal of gall bladder .

A randomized comparative study to evaluate recovery profile and hemodynamics of opioid free anesthesia versus standard balanced anesthesia technique for laproscopic cholecystectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/11/046967

Enrollment

Registered

2022-11-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: K80- Cholelithiasis Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Opioid free anesthesia(OFA) Group - Injection ketamine(bolus) followed by dexmedetomidine infusion: Injection Ketamine 0.5 mg/kg at the time of induction of anesthesia and after crea

Eligibility

Inclusion criteria

Inclusion criteria: Patients giving consent for the study and aged 20-55 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Patients with known case of cardiovascular, pulmonary, psychological or neurological diseases 2. Patients who are known to be epileptic 3. Patients who have signs and symptoms of raised intracranial tension 4. Patients with known allergies to the study drugs 5. Patients with abnormalities like heart block, left bundle branch block 6. Obese patients (BMI = 30kg/m2)

Design outcomes

Primary

Measure	Time frame
The time taken for extubation between the opioid free anesthesia versus standard balanced anesthesia groupTimepoint: The time to extubation, which is the time taken from the injection of reversal to the extubation of endotracheal tube which will be counted in minutes (the same has been used for sample size calculation as well).	—

Secondary

Measure	Time frame
To compare between the two groups- 1. Hemodynamic parameters at the time of inubation 2. Hemodynamic parameters intraoperatively 3. Hemodynamic parameters at the time of extubation 4. Post-operative recovery using modified Aldrete score (Anexure III) 5. Post-operative pain using Numeric Rating Scale (NRS) (Anexure IV) 6. Total dose of rescue analgesia required in 24 hours 7. Any adverse effects 8. To assess the quality of post operative pain using QoR-15 score Timepoint: 24 hours post operatively	—

Measure

Time frame

To compare between the two groups- 1. Hemodynamic parameters at the time of inubation 2. Hemodynamic parameters intraoperatively 3. Hemodynamic parameters at the time of extubation 4. Post-operative recovery using modified Aldrete score (Anexure III) 5. Post-operative pain using Numeric Rating Scale (NRS) (Anexure IV) 6. Total dose of rescue analgesia required in 24 hours 7. Any adverse effects 8. To assess the quality of post operative pain using QoR-15 score Timepoint: 24 hours post operatively

—

Countries

India

Contacts

Public ContactDr Robin P Thomas

UCMS and GTBH

rudoc@rediffmail.com9560678023

Outcome results

None listed

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