Survey the effect of mixture of two anesthetic drugs on control of postoperative pain of opioid dependent patients undergoing orthopedic ankle surgery.

Survey the effect of Ketodex on postoperative pain management of opioid-dependent patients undergoing orthopedic ankle surgery.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121204011662N15

Enrollment

Registered

2020-12-03

Start date

2020-12-05

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Acute pain. Other acute postprocedural pain

Interventions

Intervention 1: Intervention group: patients in group A, Ketodex infusion (Ketamine 0.1mg/Kg/min and Dexmedetomidine 0.1 mic/Kg/min ) will be started through a 50 ml syringe with the label A after ind

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: All opioid dependent patients who will be candidate for orthopedic ankle surgery under general anesthesia.

Exclusion criteria

Exclusion criteria: Patients with history of cardiovascular disorders Patients with history of seizure disorder Patients with history of brain tumor Patients with history of taking illicit medications Patients with history of psychologic disorder If general anesthetic will not be used. If patient has ASA class III or more.

Design outcomes

Primary

Measure	Time frame
Postoperative analgesia. Timepoint: Every 15 min after patients will become awake in post-anesthesia care unit (PACU). During the first 24 h, postoperative analgesia will be evaluated every 2 hr for 8 hr then every 4 hr till 24 hr. Method of measurement: By using Numerical Rating Pain Score (0= No pain,...10= the most severe pain that could imagine).	—

Secondary

Measure	Time frame
Sedation. Timepoint: Every 15 minute in PACU (post anesthesia care unit ). Method of measurement: By using Ramsay sedation score: 0 = Restless , 1 = Calm, 2 = Sleepy, 3 = Drowsy with response to verbal stimuli , 4 = Drowsy without response to verbal stimuli, 5 = Without response to painfull stimuli.;Postoperative nausea and vomiting. Timepoint: Every 4 hr. during first 24 hr. post operation. Method of measurement: By using 3-point scale: 0 = no nausea, vomiting, 1 = nausea only, and 2 = retching or/and vomiting.;Mean arterial blood pressure (MAP). Timepoint: Values will record every 15 minutes till end of surgery. Method of measurement: Non invasive blood pressure monitoring.;Heart rate per minute. Timepoint: Values will record every 15 minutes till end of surgery. Method of measurement: Electrocardiogram.	—

Measure

Time frame

Sedation. Timepoint: Every 15 minute in PACU (post anesthesia care unit ). Method of measurement: By using Ramsay sedation score: 0 = Restless , 1 = Calm, 2 = Sleepy, 3 = Drowsy with response to verbal stimuli , 4 = Drowsy without response to verbal stimuli, 5 = Without response to painfull stimuli.;Postoperative nausea and vomiting. Timepoint: Every 4 hr. during first 24 hr. post operation. Method of measurement: By using 3-point scale: 0 = no nausea, vomiting, 1 = nausea only, and 2 = retching or/and vomiting.;Mean arterial blood pressure (MAP). Timepoint: Values will record every 15 minutes till end of surgery. Method of measurement: Non invasive blood pressure monitoring.;Heart rate per minute. Timepoint: Values will record every 15 minutes till end of surgery. Method of measurement: Electrocardiogram.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadAli Sahmeddini

Shiraz University of Medical Sciences

sahmeddin@sums.ac.ir+98 71 3647 4270

Outcome results

None listed

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