Dexmedetomidine vs ketamine to reduce analgesia requirement in opioid addicts

Comparison of opioid sparing effect of low dose ketamine vs. dexmedetomidine in opioid abusers undergoing laparascopic nephrectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201307203436N3

Enrollment

100

Registered

2013-08-03

Start date

2013-08-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

opioids abuse. Mental and behavioural disorders due to use of opioids

Interventions

Intervention 1: Intervention: Pre-emptive bolus intravenous ketamine (0.1 mg/kg) with normal saline infusion (similar to other group for blinding). Intervention 2: Intervention: Intravenous dexmedetom

Prevention

Intervention: Pre-emptive bolus intravenous ketamine (0.1 mg/kg) with normal saline infusion (similar to other group for blinding)

Intervention: Intravenous dexmedetomidine (0.5 mic/kg in 10 min as loading then 0.1 mic/kg/h till the end of surgery) one bolus normal saline for blinding

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion: 1- ASA physical status I or II 2- No probability for difficult airway 3- No allergy to remifentanil, ketamine, propofol or dexmedetomidine 4- No alcohol, tranquilizer or intravenous drug abuse 5- No cognitive or memory disorder 6- No history for hypertension, Increased ICP, present pregnancy or psychiatry disorder Exclusion: 1- surgery lasts more than 4 hours 2- Mean arterial pressure (MAP) change greater than 30 % lasting more than 5 minutes 3- Pulse rate change greater than 30% lasting more than 5 minutes 4- Application of drugs not mentioned in the protocol (however data is recorded)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Post operative morphine requirement. Timepoint: (post intervention) 24 h postoperative. Method of measurement: mg.;Intra-operative remifentanil requirement. Timepoint: (during and post intervention) during surgery. Method of measurement: micrigram.	—

Secondary

Measure	Time frame
Bradypnea (RR less than 8/min). Timepoint: (after intervention) recovery. Method of measurement: pulse oximetry.;Apnea (central apnea for more than 10 sec). Timepoint: (after intervention) recovery. Method of measurement: Observation.;Itching (post-operative complaint of patient). Timepoint: (after intervention) recovery and 24 h post-operatively. Method of measurement: Observation.;Recovery discharge time. Timepoint: (after intervention) recovery. Method of measurement: minutes from arrival to discharge.;Hemodynamic instability. Timepoint: (during and after intervention) under anesthesia. Method of measurement: blood pressure and heart rate every 5 minutes (recording).	—

Measure

Time frame

Bradypnea (RR less than 8/min). Timepoint: (after intervention) recovery. Method of measurement: pulse oximetry.;Apnea (central apnea for more than 10 sec). Timepoint: (after intervention) recovery. Method of measurement: Observation.;Itching (post-operative complaint of patient). Timepoint: (after intervention) recovery and 24 h post-operatively. Method of measurement: Observation.;Recovery discharge time. Timepoint: (after intervention) recovery. Method of measurement: minutes from arrival to discharge.;Hemodynamic instability. Timepoint: (during and after intervention) under anesthesia. Method of measurement: blood pressure and heart rate every 5 minutes (recording).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBabak Gharaei

Anesthesiology Research Center, Labbafinejad Hospital, Shahid Beheshti University of Medical Science

babakgharaei@gmail.com+98 21 2360 2175

Outcome results

None listed

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