Study on comparing drug response of dexmedetomidine and ketamine with fentanyl and morphine (drug name) for laparoscopic operation

Opioid-Free versus Opioid-Based Anaesthesia for Elective Laparoscopic Surgery - A Double Blinded Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055452

Enrollment

Registered

2023-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis

Interventions

Intervention1: Dexmedetomidine and ketamine for Elective laparoscopic surgery: Patients will receive a loading dose of Dexmedetomidine 0.5 microgram per kg IV diluted to a total volume of 20ml and inf

Eligibility

Inclusion criteria

Inclusion criteria: BMI: 18.5 â?? 24.9 ASA (American Society of Anaesthesiologists) physical status of I and II

Exclusion criteria

Exclusion criteria: Pregnant and Lactating Women ASA physical status of III and IV Significant pain related neurological conditions Patients currently taking opioid Patients with allergies to study medication Patient Refusal H/O Drug Abuse, Psychiatric disease

Design outcomes

Primary

Measure	Time frame
Mean systolic blood pressure between opioid free & opioid based anesthesia study groups for elective laparoscopic surgery.Timepoint: It will be monitored at baseline, before induction, post induction 3min, before intubation, post intubation 1 min, beginning of surgery, bef ore abdominal insufflation, post abdominal insufflation 3min, 15 min,30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min & 150 min from induction , post deflation 3min, before extubation, after extubation 1min.	—

Measure

Time frame

Mean systolic blood pressure between opioid free & opioid based anesthesia study groups for elective laparoscopic surgery.Timepoint: It will be monitored at baseline, before induction, post induction 3min, before intubation, post intubation 1 min, beginning of surgery, bef ore abdominal insufflation, post abdominal insufflation 3min, 15 min,30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min & 150 min from induction , post deflation 3min, before extubation, after extubation 1min.

—

Secondary

Measure	Time frame
To compare the use of Postoperative Rescue Analgesia & the use of rescue for Postoperative Nausea & Vomiting.Timepoint: Postoperative pain will be assessed by visual analog scale score at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours.	—

Countries

India

Contacts

Public ContactP Ramyadevi

Sri Venkateshwaraa Medical College Hospital and Research Centre

Vedha83@gmail.com9894510137

Outcome results

None listed

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