NCT07543913

Brief Summary

Shivering is recognized as an undesirable effect of spinal anesthesia. Patients undergoing gynecological surgeries may experience increased physiological stress due to perioperative shivering. This condition can lead to serious complications such as increased oxygen consumption, resulting in hypoxemia, lactic acidosis, and elevated carbon dioxide production. Additionally, shivering may cause increased intraocular and intracerebral pressure and can interfere with monitoring techniques like pulse oximetry, blood pressure, and electrocardiography. If not treated, shivering can negatively impact patient outcomes, prolong recovery times, and extend hospital stays. The use of opioids has shown effectiveness in treating shivering. Based on the existing literature, it is hypothesized that there is no difference in the efficacy of nalbuphine and ketamine in controlling perioperative shivering in patients undergoing gynecological surgery under spinal anesthesia. Therefore, the study aims to investigate and compare the effectiveness of nalbuphine and ketamine in managing post-spinal shivering in these patients, focusing on i) incidence of shivering, ii) severity of shivering in both groups, iii) complications such as vomiting and sedation, and iv) the need for rescue medication. Preventing and managing shivering is crucial for successful surgical outcomes. To date, no comparative study has evaluated the intravenous efficacy of these two drugs in this patient population for post-spinal shivering control. This will be a double-blind, randomized controlled trial conducted in the Anesthesiology Department at DHQ Teaching Hospital Sargodha. A total of 90 gynecological patients will be enrolled and divided equally into two groups: Group N receiving nalbuphine and Group K receiving ketamine. Parameters such as heart rate, systolic and diastolic blood pressure, temperature, oxygen saturation, incidence and grade of shivering, complications like sedation and vomiting, and the need for rescue medication will be recorded. The study may face limitations due to the lack of advanced monitoring equipment for assessing parameters like core body temperature at the study site. Evaluations of cognitive and psychomotor functions cannot be conducted due to resource constraints. The use of a non-probability convenience sampling method, while practical, may introduce bias. Additionally, precise blinding may not be achievable due to limited technical personnel, and financial constraints prevent increasing the sample size.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 9, 2026

Last Update Submit

April 18, 2026

Conditions

Peri-operative Shivering Under Spinal Anaesthesia

Keywords

Peri-operative shivering

Outcome Measures

Primary Outcomes (2)

  • Incidence of shivering in both study groups

    Shivering will be assessed by the presence or absence of shivering.

    Within one hour post-spinal anesthesia.

  • Grades of shivering

    Shivering will be assessed by Tsai and Chu, with the grade of shivering as follows: Grade of shivering: clinical sign 0 No shivering 1. Piloerection or peripheral vasoconstriction, but no visible shivering 2. Muscular activity in only one muscle group 3. Muscular activity in more than one muscle group, but not generalized 4. Shivering involving the whole body

    After spinal anesthesia, grades of shivering were assessed at 5 minutes and then after every 10 minutes until 60 minutes.

Secondary Outcomes (7)

  • Heart rate

    After spinal anesthesia, heart rate will be assessed at 5 minutes and then after every 10 minutes until 60 minutes.

  • Oxygen Saturation

    After spinal anesthesia, oxygen saturation was assessed at 5 minutes and then after every 10 minutes until 60 minutes.

  • Systolic blood pressure

    After spinal anesthesia, systolic blood pressure was assessed at 5 minutes and then after every 10 minutes until 60 minutes.

  • Diastolic blood pressure

    After spinal anesthesia, diastolic blood was assessed at 5 minutes and then after every 10 minutes until 60 minutes.

  • Temperature

    After spinal anesthesia, temperature was assessed at 5 minutes and then after every 10 minutes until 60 minutes.

  • +2 more secondary outcomes

Other Outcomes (1)

  • Need of Rescue drug

    Within one hour post-spinal anesthesia.

Study Arms (2)

Participants assigned to this arm received injection nalbuphine.

EXPERIMENTAL

After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected in the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug Nalbuphin (0.07 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute.

Drug: Participants assigned to this arm received injection nalbuphine.

Participants assigned to this arm received injection Ketamine.

EXPERIMENTAL

After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected into the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug ketamine (0.2 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute.

Drug: Participants assigned to this arm received injection ketamine.

Interventions

Participants assigned to this arm received injection nalbuphine.DRUG

After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected in the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug Nalbuphin (0.07 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute.

Also known as: Group N
Participants assigned to this arm received injection nalbuphine.
Participants assigned to this arm received injection ketamine.DRUG

After spinal anesthesia in a sitting position at L3-L4 or L4-L5 using a 25-gauge Quincke spinal needle, 1.2 mL of 0.75% (7.5 mg) hyperbaric bupivacaine was injected into the subarachnoid space. The Bromage scale and cold test by using a spirit swab will be used to evaluate the subarachnoid block for the desired motor and sensory blocks, respectively. After spinal anesthesia, the study drug ketamine (0.2 mg/kg) will be administered intravenously to group N, and oxygen will be given through a face mask at 4 liters per minute.

Also known as: Group K
Participants assigned to this arm received injection Ketamine.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients undergoing gynecological surgery under spinal anesthesia will be recruited for the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • i. Female patients of age between 18 and 40 years undergoing gynecological surgeries (total abdominal hysterectomy, ovarian cystectomy, vaginal hysterectomy, myomectomy).
  • ii. ASA 1 and 2.

You may not qualify if:

  • i. ASA 3 and onwards as per the classification of the American Society of Anesthesiologists.
  • ii. Obstetric patients
  • iii. Patients who are allergic to study drugs.
  • iv. Patients undergoing general anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ

Sargodha, Pakistan

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An independent outcome assessor was blinded to group allocation. This assessor was not involved in administering the anesthesia and had no knowledge of whether the participants received nalbuphine or ketamine. Incidence and grades of shivering, complications of study drugs such as vomiting and sedation, and the need for rescue drugs were evaluated by this blinded assessor to minimize bias.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A double-blind randomized controlled trial was conducted on 90 patients aged 18 to 40 years undergoing gynecological surgery after written consent and randomly divided into two groups of 45 each: Group N received Nalbuphine, and Group K received Ketamine. Patients with co-morbidities were excluded. Baseline hemodynamic parameters were recorded. Spinal anesthesia will be administered at L3-L4 or L4-L5. A dose of 1.2 mL of 0.75% hyperbaric bupivacaine was injected. Motor and sensory blocks will be assessed with the Bromage scale and a cold test. Following spinal anesthesia, patients will receive either Nalbuphine (0.07 mg/kg) or Ketamine (0.2 mg/kg) intravenously. The drugs, prepared in coded syringes, will be administered by an anesthetist blinded to group assignment. Shivering and hemodynamic variables were recorded. Sedation will be assessed by the Ramsay Sedation Score. Vomiting will be clinically monitored. If shivering reaches grade 3 or above, a rescue drug is given.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-graduation resident

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 22, 2026

Study Start

April 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Your study is a single-center anesthesia comparison trial. There is no requirement to share individual participant data (IPD). Unless you have a formal data-sharing mechanism (repository, request process, timelines), selecting Yes will create extra mandatory fields.

Locations

PA(1)