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NCT Number: NCT07787702

Comparison of Low-Dose Intravenous Ketamine and Tramadol for Prevention of Post-Spinal Anaesthesia Shivering in Orthopedic Surgical Patients

This randomized controlled trial will compare the prophylactic effectiveness of low-dose intravenous ketamine and tramadol in preventing post-spinal anesthesia shivering in patients undergoing orthopedic surgery at Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT), Karachi,

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)

Karachi, Sindh, 74200, Pakistan

Location contact

Aqsa Sattar, Mbbs Fcps ( pg)

CONTACT

[email protected]

+92 342-2437774

Syed zafar Mehdi, Mbbs fcps

PRINCIPAL_INVESTIGATOR

About this study

Post-spinal anesthesia shivering is a common and undesirable phenomenon in patients undergoing surgery under spinal anesthesia. This randomized controlled trial will compare the prophylactic use of low-dose intravenous ketamine and tramadol for prevention of post-spinal anesthesia shivering in orthopedic surgical patients. A total of 106 ASA I and II patients aged 18-60 years undergoing orthopedic surgery under spinal anesthesia will be randomly allocated into two groups. The tramadol group will receive intravenous tramadol 0.5 mg/kg and the ketamine group will receive intravenous ketamine 0.25 mg/kg immediately after spinal anesthesia. Patients will be monitored for shivering, body temperature, vital signs, pain, nausea, vomiting, alertness, adverse effects, and rescue medication requirements for 90 minutes. Shivering will be assessed using a graded scale from 0 to 4.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • * ASA I and II patients aged 18-60 years.
  • Both genders.
  • Patients undergoing orthopedic surgery under spinal anesthesia.

Exclusion criteria

  • * Patient refusal.
  • ASA III and ASA IV.
  • Prolonged surgical procedures expected to be more than 90 minutes.
  • Patients who received blood transfusion or study drugs other than for the study purpose.

Treatment and study plan

Tramadol

Drug

Intravenous tramadol 0.5 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

ketamin

Drug

Intravenous ketamine 0.25 mg/kg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.

Primary outcomes

  1. Incidence of post-spinal anesthesia shivering

    Time frame: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia

    Shivering will be assessed after spinal anesthesia and the occurrence of post-spinal anesthesia shivering will be recorded.

Secondary outcomes

  1. Severity of post-spinal anesthesia shivering

    Time frame: immediately after spinal anesthesia until 90 minutes post-spinal anesthesia

    Severity of post-spinal anesthesia shivering will be assessed and recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Aqsa Sattar, Mbbs Fcps 2( pg)

CONTACT

[email protected]

+92 342-2437774

Sponsors and collaborators

Lead sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Other

Registry information

Official study title

To Compare the Prophylactic Use of Low Doses of Intravenous Ketamine and Tramadol for the Prevention of Post Spinal Anaesthesia Shivering in Orthopedic Surgical Patients at Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT) Karachi, Sindh, Pakistan

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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